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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT01489358
Description: For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
Frequency Threshold: 5
Time Frame: Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
Study: NCT01489358
Study Brief: Chikungunya Virus Vaccine Trial in Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 None None 0 5 4 5 View
Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 None None 0 10 9 10 View
Group 3: 40 mcg VRC-CHKVLP059-00-VP Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 None None 0 10 8 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.0) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View
Incisional drainage NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (16.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.0) View
Pain/Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View