Adverse Events Module

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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: 2025-12-25 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT02314260
Description: In our study the only serious adverse event recorded was Caesarean section, which occurred when labour progress stopped,\& labour induction was considered to be a failure. In the 5 months total time to complete study, other adverse events not related to successful labour induction were not recorded e.g postpartum hemorrhage, wound infection e.t.c
Frequency Threshold: 0
Time Frame: 5 months. total time to complete study, other adverse events not related to successful labour induction were not recorded e.g postpartum hemorrhage, wound infection e.t.c
Study: NCT02314260
Study Brief: Modifying Cervical Bishop Scoring System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Labour Induction 80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length \&, Modified bishop score calculation, then induction of labour at our hospital. bishop score calculation: Assessment of bishop score by vaginal examination Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length. Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score labour induction: Induction of labor was carried out as per our hospital's standard protocol. None None 18 80 0 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
failed labour induction SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):