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 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
NCT ID:
NCT06060457
Description:
All-cause mortality based on randomization set. SAEs and other (not including serious) AEs based on safety set (all randomized participants who received any study vaccination). Participants included in treatment arm corresponding to study drug they actually received. Per prespecified analysis, all-cause mortality, SAE, and other (not including serious) AE data were collected by arm assignment of "Fluzone HD + mRNA-1345 Followed by Placebo" or "Fluzone HD + Placebo Followed by mRNA-1345".
Frequency Threshold:
5
Time Frame:
All-cause mortality and serious adverse events were collected Day 1 up to Day 202. Other (not including serious) unsolicited adverse events were collected up to 21 days after each study injection (that is, Day 1 up to Day 21 for the first injection and Day 22 up to Day 43 for the second injection).
Study:
NCT06060457
Study Brief:
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fluzone HD + mRNA-1345 Followed by Placebo | Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22. | 2 | None | 23 | 947 | 0 | 947 | View |
| Fluzone HD + Placebo Followed by mRNA-1345 | Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. | 2 | None | 33 | 946 | 0 | 946 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Septic encephalopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Chronic lymphocytic leukaemia stage 1 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Meningioma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Toxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| Acute left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Diverticulum intestinal haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Gastrointestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Fibrin D dimer increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Central cord syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Dislocation of vertebra | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Traumatic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 25.0 | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
Other Events(If Any):