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 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
NCT ID:
NCT04530604
Description:
Participants were already hospitalized and extremely sick so SAEs or AEs after treatment was completed are noted by footnote.
AEs present at baseline were not recorded as AE, provided there was no clinical worsening of the event during study therapy. Of the 10 out of 12 patients with baseline grade 4 respiratory toxicity, all received mechanical ventilation, and 3 had subsequent progression of respiratory disease and died from progressive respiratory failure after completing study therapy.
Frequency Threshold:
0
Time Frame:
For death and SAEs, participants were followed up at 30 days after completion of therapy; for most participants, 37 days up to a maximum of 44 days. The "other adverse events" table includes any AE (grade 1-5) that occurred during receipt of study drug therapy. Data was collected only during study treatment (7 days for most participants; 14 days for 1).
Study:
NCT04530604
Study Brief:
Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Defibrotide | Defibrotide: All patients received 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV). The planned duration of study therapy was 7 days (while in the hospital), with the following qualifications: * Patients who responded to study therapy prior to day 7 (able to discontinue oxygen) discontinued study therapy at that earlier time point. * Patients who did not respond to study therapy by day 7 of therapy, evidenced by \<20% reduction (or a worsening) of the amount of supplemental oxygen they were receiving, discontinued study therapy at day 7. * Patients who had evidence of a partial pulmonary response by day 7 (\>20% reduction in supplemental oxygen requirement, but still requiring supplemental oxygen) could elect to continue to receive study drug through an additional 7 days of study (total 14-day therapy course). | 3 | None | 6 | 12 | 9 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Bacterial Infections (Other) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Skin (rash) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Pulmonary Bacterial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| ECMO | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE 5.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 5.0 | View |
| bleeding/ hemorraghic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 5.0 | View |
| Pulmonary Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Neurologic (Other) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Tracheostomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 5.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 5.0 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 5.0 | View |
| Pulmonary Infections (bacterial) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Increased ALT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Increased AST | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Uremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| alkalosis | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 5.0 | View |
| ECMO | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE 5.0 | View |