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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group ETT (Endo Tracheal Tube) | Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482 Laryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted. Other Names: LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7 | 0 | None | 0 | 50 | 0 | 50 | View |
| Group LM-S(Laryngeal Mask Supreme Group) | Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert. Endotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482 | 0 | None | 0 | 50 | 0 | 50 | View |