Trial Outcomes & Findings for Proton Therapy in Reducing Toxicity in Anal Cancer (NCT NCT03018418)

NCT ID: NCT03018418

Last Updated: 2024-09-19

Results Overview

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Patients With Stage II and III Anal Cancer Patients with histologically confirmed squamous or basaloid carcinoma of the anal canal were eligible if they were at least 18 years old with a Karnofsky performance status \> 70%, AJCC eighth edition cT2-4 disease with any N category, life expectancy \>3 months, and acceptable organ and bone marrow function. Women who were not postmenopausal had to have a negative urine or serum pregnancy test. History and physical examination (including anal and groin evaluation) had to be performed within 21 days of trial registration.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Therapy in Reducing Toxicity in Anal Cancer

Baseline characteristics by cohort

Measure	Proton Therapy and Chemotherapy n=14 Participants Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy Proton therapy: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions Chemotherapy: 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Rates of Acute Toxicity	12 Participants

SECONDARY outcome

Timeframe: every 6 months up to 60 months

Population: The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Rates of Late Toxicity	6 Participants

SECONDARY outcome

Timeframe: at 6 months from the completion of chemoradiation

Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence.

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Complete Response Rate	11 Participants

SECONDARY outcome

Timeframe: every 6 months up to 60 months

This is the percentage of subjects that were free of local progression.

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Local Progression Free Survival	12 Participants

SECONDARY outcome

Timeframe: every 6 months up to 24 months

Population: time from the date of registration to the date of death due to all causes

This is an estimated percentage of participants that is alive at 2 years.

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Overall Survival	76 percentage of subjects Interval 73.0 to 92.0

SECONDARY outcome

Timeframe: every 6 months up to 60 months

This is the percentage of subjects that were free of distant metastases.

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Distant Metastases Free Survival	13 Participants

SECONDARY outcome

Timeframe: before treatment and 12 months after start of treatment

Population: This measure examines all 14 subjects.

Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points.

Outcome measures

Measure	Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity n=14 Participants Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic
Quality of Life Changes	9 Participants

Adverse Events

Adverse Events for All 14 Subjects

Serious events: 7 serious events

Other events: 13 other events

Deaths: 2 deaths

Serious adverse events

Measure	Adverse Events for All 14 Subjects n=14 participants at risk This is a summary of adverse events for all 14 subjects in the study.
Renal and urinary disorders Acute kidney injury	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Blood and lymphatic system disorders Anemia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Bullous dermatitis	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Cardiac disorders Cardiac disorders - Other, specify	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Cardiac disorders Chest pain - cardiac	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Dermatitis radiation	7.1% 1/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Vascular disorders Hypertension	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Infections and infestations Infections and infestations - Other, specify	7.1% 1/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Psychiatric disorders Psychiatric disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Rectal pain	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	7.1% 1/14 • Number of events 5 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders - Other, specify	7.1% 1/14 • Number of events 4 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary tract infection	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.

Other adverse events

Measure	Adverse Events for All 14 Subjects n=14 participants at risk This is a summary of adverse events for all 14 subjects in the study.
Gastrointestinal disorders Abdominal pain	42.9% 6/14 • Number of events 11 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Anal hemorrhage	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Anal pain	57.1% 8/14 • Number of events 8 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Blood and lymphatic system disorders Anemia	42.9% 6/14 • Number of events 19 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Anorexia	50.0% 7/14 • Number of events 11 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Bruising	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Bullous dermatitis	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Burn	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Cardiac disorders Tachycardia	21.4% 3/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Chills	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Creatinine increased	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Dermatitis radiation	85.7% 12/14 • Number of events 20 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Diarrhea	71.4% 10/14 • Number of events 18 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Nervous system disorders Dysgeusia	35.7% 5/14 • Number of events 7 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Edema limbs	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Fatigue	64.3% 9/14 • Number of events 9 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Fecal incontinence	21.4% 3/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Fever	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Flatulence	42.9% 6/14 • Number of events 10 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Eye disorders Floaters	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	21.4% 3/14 • Number of events 4 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Hematuria	7.1% 1/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Hoarseness	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Vascular disorders Hot flashes	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hyperglycemia	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hypoglycemia	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Vascular disorders Hypotension	14.3% 2/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Immune system disorders Immune system disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Infections and infestations Infections and infestations - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Localized edema	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Lymphocyte count decreased	64.3% 9/14 • Number of events 35 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Mucositis oral	35.7% 5/14 • Number of events 7 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Muscle cramp	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Nausea	71.4% 10/14 • Number of events 19 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Nervous system disorders Nervous system disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Neutrophil count decreased	42.9% 6/14 • Number of events 9 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Non-cardiac chest pain	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Oral pain	14.3% 2/14 • Number of events 4 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
General disorders Pain	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Nervous system disorders Paresthesia	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Reproductive system and breast disorders Pelvic pain	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Platelet count decreased	64.3% 9/14 • Number of events 15 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Proctitis	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Rectal hemorrhage	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Rectal pain	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Renal and urinary disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Cardiac disorders Sinus tachycardia	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	14.3% 2/14 • Number of events 3 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Skin ulceration	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary frequency	57.1% 8/14 • Number of events 10 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary incontinence	35.7% 5/14 • Number of events 6 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary retention	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Infections and infestations Urinary tract infection	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary tract pain	28.6% 4/14 • Number of events 7 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary urgency	35.7% 5/14 • Number of events 6 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Renal and urinary disorders Urine discoloration	35.7% 5/14 • Number of events 5 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Reproductive system and breast disorders Vaginal discharge	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Reproductive system and breast disorders Vaginal dryness	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Reproductive system and breast disorders Vaginal hemorrhage	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Gastrointestinal disorders Vomiting	42.9% 6/14 • Number of events 7 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Weight gain	7.1% 1/14 • Number of events 1 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations Weight loss	14.3% 2/14 • Number of events 2 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.
Investigations White blood cell decreased	71.4% 10/14 • Number of events 24 • AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs. The definition does not differ from clinicaltrials.gov.

Additional Information

Jordan Kharofa, MD

University of Cincinnati Cancer Center

Phone: 513-584 4775

Email: kharofjr@ucmail.uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place