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 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT02738450
Description: Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 0
Time Frame: The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96.
Study: NCT02738450
Study Brief: Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACI-24 300µg Cohort 1: Low dose 0 None 0 6 5 6 View
ACI-24 1000µg Cohort 2: High dose 0 None 0 6 6 6 View
Placebo Cohort 1 Cohort 1: Placebo 0 None 0 2 2 2 View
Placebo Cohort 2 Cohort 2: Placebo 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Neoplasms benign, malignant and unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.1 View