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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:24 AM
NCT ID: NCT01187433
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
Study: NCT01187433
Study Brief: Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. None None 3 50 25 50 View
CYD Dengue Vaccine Group Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. None None 5 100 61 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Intra uterine death NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 12.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal wall abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Headache: Post Any Injection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Injection site Pain; Post Any Injection SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site Swelling; Post Any Injection SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Fever; Post Any Injection SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Malaise; Post-Any Injection SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Asthenia; Post-Any Injection SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Myalgia; Post-Any Injection SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View