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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
NCT ID:
NCT05280158
Description:
The High Dose Group did not have any enrolled participants in this study. This decision was influenced by the availability of the vaccine to the public starting in September 2022. Therefore, results for this arm/group are not reported
Frequency Threshold:
0
Time Frame:
Adverse events were collected throughout the study, Visit 1 (Day 1) through Visit 6 (Day 180)
Study:
NCT05280158
Study Brief:
High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard-dose | mRNA-1273 (Moderna COVID-19 vaccine) 50 ug mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study. | 0 | None | 1 | 8 | 5 | 8 | View |
| Mid-Dose | mRNA-1273 (Moderna COVID-19 vaccine) 100 ug mRNA-1273 (Moderna COVID-19 vaccine): Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study. | 0 | None | 2 | 11 | 10 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID 19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Aspiration pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Post-op chest paqin | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Mitral valve regurgitation (MR) and aortic valve regurgitation (AR) post valve replacement surgery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acute hypoxic respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Post-aspiration pneumonia dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Chest heaviness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| COVID 19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Increased Creatinine | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Joint irritation, foot and hand | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Edema of lower extremity | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Flank pain, left | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lightheadedness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mechanical trip and fall | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea/Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain in extremity - bilateral shoulder | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain in extremity - left foot | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest discomfort worsening | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Shortness of breath worsening | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Mitral regurgitation worsening | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |