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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
NCT ID:
NCT04860258
Description:
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Frequency Threshold:
5
Time Frame:
Up to Day 57
Study:
NCT04860258
Study Brief:
COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Chronic Kidney Disease | Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m². | 0 | None | 0 | 1 | 1 | 1 | View |
| COPD | Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis. | 0 | None | 0 | 1 | 1 | 1 | View |
| Obesity | Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m². | 0 | None | 0 | 52 | 50 | 52 | View |
| Chronic Cardiovascular Disease | Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension. | 0 | None | 0 | 33 | 32 | 33 | View |
| Type 2 Diabetes Mellitus | Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\]. | 0 | None | 1 | 7 | 7 | 7 | View |
| Renal Transplant | Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection. | 0 | None | 0 | 2 | 2 | 2 | View |
| Chronic HIV Infection | Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed. | 0 | None | 0 | 33 | 33 | 33 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Vaccination site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 24.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Syphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Parosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 24.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 24.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |