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 |
|---|---|---|---|---|---|---|---|---|
| Methylnaltrexone Oral Tablets | Methylnaltrexone oral tablets (total 450 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet | 0 | None | 0 | 4 | 1 | 4 | View |
| Methylnaltrexone Subcutaneous Injection | Methylnaltrexone 12mg subcutaneous injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution | 0 | None | 0 | 3 | 3 | 3 | View |
| Naloxegol Oral Tablets | Naloxegol oral tablets (total 25 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet | 0 | None | 0 | 5 | 2 | 5 | View |