Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-25 @ 12:14 PM
NCT ID:
NCT00945061
Description:
None
Frequency Threshold:
0
Time Frame:
up to 5 years
Study:
NCT00945061
Study Brief:
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intracavitary Balloon Brachytherapy | Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. | 0 | None | 0 | 1 | 1 | 1 | View |
| Intraoperative Radiation Therapy | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. | 1 | None | 0 | 12 | 11 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V3 | View |
| Hemorrhage, pulmonary/upper respiratory - nose | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V3 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE V3 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V3 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V3 | View |
| Rigors/chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V3 | View |
| Burn | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Breast indentation/dimpling | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Skin retraction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Skin dimpling | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Induration/fibrosis (skin and subcutaneous tissue) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Nail changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Rash: dermatitis associated with radiation - Radiation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Telangiectasia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V3 | View |
| Hot flashes/flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE V3 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V3 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V3 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V3 | View |
| Heartburn/dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V3 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V3 | View |
| Breast Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V3 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V3 | View |
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V3 | View |
| Edema: trunk/genital | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V3 | View |
| Lymphatics: seroma | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V3 | View |
| Glucose, serum-low (hypoglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V3 | View |
| Arthritis (non-septic) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Extremity-lower (gait/walking) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Fibrosis-cosmesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Joint-function | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Superficial soft tissue breast fibrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V3 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V3 | View |
| Mood alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V3 | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V3 | View |
| Pain - Breast | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Dental/teeth/peridontal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Extremity-limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Joint | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Pelvis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Pain - Skin | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | View |
| Nasal cavity/paranasal sinus reactions | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | View |
| Breast nipple/areolar deformity | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V3 | View |
| Nipple Inversion | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V3 | View |
| Intra-operative injury - Skin | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE V3 | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V3 | View |