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 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
NCT ID:
NCT01809132
Description:
The definitions of adverse events are the same as those used in clinicaltrials.gov Adverse events were not collected for the observational arm.
Frequency Threshold:
5
Time Frame:
6 months
Study:
NCT01809132
Study Brief:
Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Anakinra & Pentoxifylline & Zinc Sulfate | anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement | 17 | None | 33 | 53 | 20 | 53 | View |
| Methylprednisolone | methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid | 22 | None | 30 | 50 | 4 | 50 | View |
| Observational | Individuals who choose not to participate in the interventional arm of the trial will receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Upper GI hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Aspergillus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Nocardia sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Histoplasmosis infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Baceteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Viremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Acute Respiratory Distress Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Multiple Organ Dysfunction Syndrome (MODS) | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| Esophageal varices hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematemesis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| C. difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |