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 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
NCT ID:
NCT04583592
Description:
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
Frequency Threshold:
0
Time Frame:
28 Days
Study:
NCT04583592
Study Brief:
Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Camostat Mesilate | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | 1 | None | 10 | 195 | 8 | 195 | View |
| Placebo | Participants will receive placebo for 14 days in addition to standard of care treatment. Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. | 0 | None | 5 | 99 | 9 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Decreased apetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Anosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Aguesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |