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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT04786457
Description: Daily AEs were assessed.
Frequency Threshold: 0
Time Frame: Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Study: NCT04786457
Study Brief: ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vaccinees Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine 0 None 0 6 5 6 View
Controls Not previously vaccinated with tetravalent dengue vaccine 0 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye Pain / Headache SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint or Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Immune system disorders None View
Nausea or Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View