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 |
|---|---|---|---|---|---|---|---|---|
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. Intravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group | 0 | None | 7 | 29 | 0 | 29 | View |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. Intravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. | 0 | None | 8 | 42 | 0 | 42 | View |
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. Intravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group | 0 | None | 2 | 52 | 0 | 52 | View |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. Intravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. | 0 | None | 3 | 46 | 0 | 46 | View |