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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT00788151
Description: Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Frequency Threshold: 5
Time Frame: Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Study: NCT00788151
Study Brief: Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CYD Dengue Vaccine Group Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). 0 None 2 199 71 199 View
Control Group Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). 0 None 4 99 29 99 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vascular purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Epiphyseal disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site Pain; Post-injection 1, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Erythema; Post-injection 1, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Swelling; Post-injection 1, all participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Pain; Post-injection 2, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Pain; Post-injection 3, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Swelling; Post-injection 3, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site Erythema; Post-injection 3, All participants SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View