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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT04576702
Description:
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Frequency Threshold:
5
Time Frame:
Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination
Study:
NCT04576702
Study Brief:
Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Investigational aIIV4c Group | aIIV4c will be administered as a single dose intramuscularly on Day 1 Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 1 | None | 2 | 116 | 86 | 116 | View |
| Licensed IIV4c Group | IIV4c will be administered as a single dose intramuscularly on Day 1 IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 0 | None | 1 | 119 | 77 | 119 | View |
| Licensed aIIV4 Group | aIIV4 will be administered as a single dose intramuscularly on Day 1 aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 0 | None | 4 | 116 | 84 | 116 | View |
| Licensed RIV4 Group | RIV4 will be administered as a single dose intramuscularly on Day 1 RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 0 | None | 6 | 120 | 83 | 120 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.0 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 24.0 | View |
| Enterocutaneous fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.0 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 24.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.0 | View |
| Scrotal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 24.0 | View |
| Anaemia postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 24.0 | View |
| Clear cell renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.0 | View |
| Guillain-Barre syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 24.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 24.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 24.1 | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 24.1 | View |
| loss of appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 24.1 | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 24.1 | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 24.1 | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 24.1 | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 24.1 | View |