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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Idelalisib 100mg | Idelalisib is an orally-administered, selective inhibitor of Phosphoinositide 3 kinase (PI3K)-delta which has been shown to be extremely effective in inducing partial to complete responses in many B-cell derived malignancies. intervention: 100mg Idelalisib twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant Idelalisib 100 MG: 100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant. | 2 | None | 7 | 9 | 9 | 9 | View |
| Placebo Oral Tablet | Placebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant Placebo Oral Tablet: placebo | 0 | None | 4 | 7 | 7 | 7 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lung Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| increased Alanine transaminase (ALT) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Increased Aspartate Transferase (AST) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Increased bilirubin | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Hemorrhagic cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Nausea and vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Decreased platelet count | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| idelalisib or placebo held for >14 days | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Graft versus host disease (GVHD) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |