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 @ 1:06 PM
Ignite Modification Date:
2025-12-25 @ 12:21 PM
NCT ID:
NCT04917861
Description:
The all-cause mortality was based on the randomized set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received any study injection. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose \[2-Dose Regimen\] and mRNA-1893 Low Dose \[2-Dose Regimen\]) in Randomized Set and Safety Set for collection and reporting data.
Frequency Threshold:
5
Time Frame:
All-cause mortality and serious adverse events were collected from Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period. Other (not including serious) unsolicited adverse events were collected up to 28 days after study injection (that is, Day 1 up to Day 57) unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation.
Study:
NCT04917861
Study Brief:
A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Study: Placebo | Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29). | 0 | None | 5 | 201 | 18 | 201 | View |
| Main Study: mRNA-1893 Low Dose (2-Dose Regimen) | Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29). | 0 | None | 2 | 202 | 20 | 202 | View |
| Main Study: mRNA-1893 High Dose (2-Dose Regimen) | Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29). | 0 | None | 4 | 202 | 24 | 202 | View |
| Extension Period: Placebo | Participants were followed up for up to Day 700 in the extension period. | 0 | None | 5 | 113 | 8 | 113 | View |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Participants were followed up for up to Day 700 in the extension period. | 1 | None | 4 | 109 | 5 | 109 | View |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Participants were followed up for up to Day 700 in the extension period. | 0 | None | 7 | 116 | 10 | 116 | View |
| Main Study: mRNA-1893 High Dose (1-Dose Regimen) | Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations. | 1 | None | 7 | 198 | 16 | 198 | View |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Participants were followed up for up to Day 700 in the extension period. | 0 | None | 5 | 104 | 8 | 104 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Diabetic foot infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Large intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 27.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 27.0 | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| Factitious disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 27.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 27.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Rotator cuff tear arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 27.0 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 27.0 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 27.0 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 27.0 | View |
| BRCA1 gene mutation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 27.0 | View |
| Heart disease congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 27.0 | View |
| Trisomy 21 | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 27.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| Burns second degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |