Adverse Events Module

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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT02127632
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02127632
Study Brief: Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery
Event Groups(If Any):

Event Groups

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
Serious Events(If Any):
Other Events(If Any):