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 |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml | None | None | 0 | 35 | 0 | 35 | View |
| Bupivacaine With Neostimgine 8 mcg/ml | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine | None | None | 0 | 38 | 0 | 38 | View |
| Bupivacaine and Neostigmine 4 mcg/ml | STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine | None | None | 0 | 40 | 0 | 40 | View |
| Bupivacaine With Neostigmine 2 mcg/ml | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine | None | None | 0 | 38 | 0 | 38 | View |