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: 2025-12-24 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT00099632
Description: Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
Frequency Threshold: 5
Time Frame: From first treatment date to 12 weeks of follow up.
Study: NCT00099632
Study Brief: Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
7-day 3TC/ZDV SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV None None 2 73 0 73 View
21-day 3TC/ZDV SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV None None 0 68 0 68 View
7-day FTC/TDF SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF None None 1 75 0 75 View
21-day FTC/TDF SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF None None 0 67 0 67 View
7-day LPV/r SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r None None 1 71 0 71 View
21-day LPV/r SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r None None 0 68 0 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Uterine rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Intra-uterine death SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.0 View
Stillbirth SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.0 View
Other Events(If Any):