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 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 10:19 AM
NCT ID:
NCT05033561
Description:
Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Frequency Threshold:
0
Time Frame:
6 months
Study:
NCT05033561
Study Brief:
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
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 A | Administration of 2 doses of nOPV2, 1 week apart | 0 | None | 8 | 298 | 217 | 298 | View |
| Group B | Administration of 2 doses of nOPV2, 2 weeks apart | 0 | None | 7 | 304 | 247 | 304 | View |
| Group C | Administration of 2 doses of nOPV2, 4 weeks apart | 1 | None | 9 | 303 | 238 | 303 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Amoebic dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Abscess neck | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Hereditary haemolytic anemia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDra 24.1 | View |
| Hereditary spherocytosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDra 24.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal crying | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |
| Loss of apetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Amoebic Dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Amoebiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Viral Rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Vaccination site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 24.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 24.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 24.1 | View |
| Seborrheic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 24.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 24.1 | View |