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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT04376502
Description:
None
Frequency Threshold:
0
Time Frame:
2 years
Study:
NCT04376502
Study Brief:
Immune Checkpoint Inhibitor and MR-guided SBRT for Limited Progressive Metastatic Carcinoma.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Radiation Therapy (RT) | RT for all subjects will consist of treating one tumor of the treating physician's preference (40 Gy in 5 fractions), and after a 1-week interval during which Immune checkpoint inhibitor (ICI) is continued alone, RT will be given to a second and separate tumor (30 Gy in 5 fractions). Radiation Therapy: Radiation therapy for all subjects will consist of treating one tumor of the treating physician's preference (40 Gray (Gy) in 5 fractions), and after a 1-week interval during which ICI is continued alone, radiation therapy will be given to a second and separate tumor (30 Gy in 5 fractions). | 6 | None | 3 | 11 | 9 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Infections and infestations - Other, COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Peripheral neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Aspartate aminotransferase increase | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alanine aminotransferase increase | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Dermatitis radiation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Bacteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Generalized edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hepatobiliary disorders - Other, Biliary ductal dilation | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (5.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Infections and infestations - Other, Metapneumovirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Investigations - Other, Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Watering eyes | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |