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 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
NCT ID:
NCT00581256
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00581256
Study Brief:
A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive 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 |
|---|---|---|---|---|---|---|---|---|
| IMRT | Best Delivery-optimized radiotherapy technique (IMRT) IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume. | None | None | 1 | 28 | 27 | 28 | View |
| 3DRT | Best 3-dimensional standard PWTF technique 3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease | None | None | 0 | 26 | 23 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection with normal ANC or Grade 1 or 2 neutrophils | None | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Creatinine | None | Investigations | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Investigations | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Breast nipple/areolar deformity | None | Reproductive system and breast disorders | None | View |
| Breast volume/hypoplasia | None | Reproductive system and breast disorders | None | View |
| Burn | None | Skin and subcutaneous tissue disorders | None | View |
| Cardiac General - Other | None | Cardiac disorders | None | View |
| Dermatology/Skin - Other | None | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Edema: limb | None | Vascular disorders | None | View |
| Edema: trunk/genital | None | Vascular disorders | None | View |
| Extremity-lower (gait/walking) | None | Musculoskeletal and connective tissue disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Fibrosis-deep connective tissue | None | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal - Other | None | Gastrointestinal disorders | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Hot flashes/flushes | None | General disorders | None | View |
| Hyperpigmentation | None | Skin and subcutaneous tissue disorders | None | View |
| Induration/fibrosis (skin and subcutaneous tissue) | None | Skin and subcutaneous tissue disorders | None | View |
| Infection with Grade 3 or 4 neutrophils | None | Infections and infestations | None | View |
| Irregular menses (change from baseline) | None | Reproductive system and breast disorders | None | View |
| Joint-function | None | Musculoskeletal and connective tissue disorders | None | View |
| Left ventricular diastolic dysfunction | None | Cardiac disorders | None | View |
| Leukocytes (total WBC) | None | Blood and lymphatic system disorders | None | View |
| Lymphatics - Other | None | Blood and lymphatic system disorders | None | View |
| Lymphedema-related fibrosis | None | Blood and lymphatic system disorders | None | View |
| Lymphopenia | None | Blood and lymphatic system disorders | None | View |
| Mood alteration | None | Psychiatric disorders | None | View |
| Muscle weakness, generalized | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal/Soft Tissue - Other | None | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neuropathy: motor | None | Nervous system disorders | None | View |
| Pain | None | General disorders | None | View |
| Pain - Other | None | General disorders | None | View |
| Pruritus/itching | None | Skin and subcutaneous tissue disorders | None | View |
| Pulmonary/Upper Respiratory - Other | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Rash: dermatitis associated with radiation | None | Skin and subcutaneous tissue disorders | None | View |
| Seroma | None | Injury, poisoning and procedural complications | None | View |
| Sexual/Reproductive Function - Other | None | Reproductive system and breast disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Investigations | None | View |
| Telangiectasia | None | Vascular disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Vaginal dryness | None | Reproductive system and breast disorders | None | View |
| Arthritis (non-septic) | None | Musculoskeletal and connective tissue disorders | None | View |
| Atrophy, skin | None | Skin and subcutaneous tissue disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermal change lymphedema, phlebolymphedema | None | Skin and subcutaneous tissue disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | None | Infections and infestations | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Otitis, middle ear (non-infectious) | None | Ear and labyrinth disorders | None | View |