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 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
NCT ID:
NCT02173704
Description:
Serious adverse events were analysed based on the unsolicited safety set and other adverse events were analysed based on the overall safety set. Therefore, the number of participants at risk in the serious adverse events are lesser compared to the number of participants at risk in the other adverse events.
Frequency Threshold:
5
Time Frame:
Solicited local AEs and systemic symptoms: from Day 1 to Day 7 after each vaccination; Unsolicited AEs and SAEs: throughout the study period (from Day 1 to Day 335).
Study:
NCT02173704
Study Brief:
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bexsero + Routine Group | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. | 0 | None | 13 | 145 | 148 | 148 | View |
| Routine Group | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. | 0 | None | 8 | 72 | 72 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Exanthema subitum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pyuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Kawasaki's disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Croup infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Respiratory syncytial virus bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Salmonella bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Exanthema subitum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Crying | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Eating disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Dermatitis diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |