NCT00807768 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 9 / 283 | 245 / 283 | Not reported / Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 32 / 290 | 284 / 290 | Not reported / Not reported |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 290
- term
- Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Leukocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 290
- term
- Cardipulmonary Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Death No Ctcae Term - Death Nos
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Pruritus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Urticaria
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Proctitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 290
- term
- Diarrhea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 290
- term
- Febrile Neutropenia
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 290
- term
- Allergic Reaction/Hypersensitivity
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 290
- term
- Rhinitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 290
- term
- Hearing (Without Monitoring Program)
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 290
- term
- Tinnitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 227
- num At Risk
- 290
- term
- Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 135
- num At Risk
- 290
- term
- Platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 290
- term
- Blood/Bone Marrow - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 107
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 234
- num At Risk
- 290
- term
- Leukocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 290
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 93
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 206
- num At Risk
- 290
- term
- Hemoglobin
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- S/N Arrhythmia: Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 290
- term
- Palpitations
Complete source fields
- event Groups
- description
- Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- EG000
- other Num Affected
- 245
- other Num At Risk
- 283
- serious Num Affected
- 9
- serious Num At Risk
- 283
- title
- Arm I (Pelvic Radiation Therapy)
- description
- Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- EG001
- other Num Affected
- 284
- other Num At Risk
- 290
- serious Num Affected
- 32
- serious Num At Risk
- 290
- title
- Arm II (Brachytherapy, Paclitaxel, Carboplatin)
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 290
- term
- Allergic Reaction/Hypersensitivity
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 290
- term
- Rhinitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 290
- term
- Hearing (Without Monitoring Program)
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 290
- term
- Tinnitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 227
- num At Risk
- 290
- term
- Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 42
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 135
- num At Risk
- 290
- term
- Platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 290
- term
- Blood/Bone Marrow - Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 107
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 234
- num At Risk
- 290
- term
- Leukocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 290
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 93
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 206
- num At Risk
- 290
- term
- Hemoglobin
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- S/N Arrhythmia: Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 290
- term
- Palpitations
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 290
- term
- Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Leukocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 290
- term
- Cardipulmonary Arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Death No Ctcae Term - Death Nos
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Pruritus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Urticaria
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Proctitis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 290
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 290
- term
- Diarrhea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (3.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 283
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 290
- term
- Febrile Neutropenia
- time Frame
- AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.
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