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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT05169905
Description: None
Frequency Threshold: 0
Time Frame: Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
Study: NCT05169905
Study Brief: A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RSV_dTpa-P Group Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization. 0 None 0 1 1 1 View
RSV_dTpa-A Group Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization. 0 None 0 3 2 3 View
dTpa_RSV-A Group Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31. 0 None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Administration site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Administration site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Hypomenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View