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 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
NCT ID:
NCT00186992
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events collected from the time of enrollment out to 10 years or 18 years of age post treatment.
Study:
NCT00186992
Study Brief:
Radiation Therapy to Treat Musculoskeletal Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment | Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations. image-guided radiotherapy: Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated. A total of 202 patients were enrolled in the study. Of 202 patients, 167 patients completed the study requirements, progression, death, and secondary malignancy, 9 patients still are in follow-up, and 26 patients were off study early due to parent or patient request, PI discretion, physician's discretion, Ineligible, and not returning to St. Jude. Completed ACT trial. | 2 | None | 9 | 199 | 50 | 199 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Middle ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Wound-infectious | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hepatic-Other | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Musculoskeletal-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Dermatology/Skin-Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Radiation dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Gastrointestinal-Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Mucositis due to radiation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Melena/GI bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Febrile neutropenia (fever of unknown origin | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Ocular-Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain due to radiation, 900180 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary-Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Renal/Genitourinary-Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Sexual/Reproductive Function-Other | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (2.0) | View |
| Musculoskeletal-Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Keratitis (corneal inflammation/corneal ulceration | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Pain due to radiation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Syndromes-Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |