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 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
NCT ID:
NCT02640404
Description:
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 (i.e., solicited) 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:
Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age).
Study:
NCT02640404
Study Brief:
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Menactra® Vaccine (9 to 23 Months) | Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1). | 0 | None | 16 | 112 | 86 | 112 | View |
| Menactra® Vaccine (2 to 55 Years) | Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0. | 0 | None | 0 | 112 | 49 | 112 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 19.0 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Febrile convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 19.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | View |
| Respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 19.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 19.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 19.0 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 19.0 | View |
| Crying | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 19.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 19.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 19.0 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 19.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 19.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 19.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 19.0 | View |