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 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT05329220
Description:
None
Frequency Threshold:
5
Time Frame:
Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Study:
NCT05329220
Study Brief:
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A Cohort 1 ABNCoV2 | Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1 | 0 | None | 2 | 34 | 6 | 34 | View |
| Part A Cohort 1 Comirnaty | Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1 | 0 | None | 0 | 34 | 4 | 34 | View |
| Part A Cohort 2 ABNCoV2 | Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1 | 1 | None | 3 | 277 | 40 | 277 | View |
| Part A Cohort 2 Comirnaty | Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1 | 1 | None | 7 | 277 | 47 | 277 | View |
| Part B Cohort 1 ABNCoV2 | Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1 | 0 | None | 23 | 1438 | 36 | 1438 | View |
| Part B Cohort 2 ABNCoV2 | Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1 | 1 | None | 49 | 2145 | 125 | 2145 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Abdominal wall abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Arthritis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Helicobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Large intestine infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Liver abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Pelvic inflammatory disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Perirectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Dengue fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Myocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Post procedural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Spinal cord injury cervical | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Wound necrosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Acoustic neuroma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Brain cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Breast cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Endometrial adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Lung cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Oropharyngeal squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Small cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 25.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 25.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 25.0 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 25.0 | View |
| End stage renal disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 25.0 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 25.0 | View |
| Obstructive nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 25.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Bipolar disease | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Delirium tremens | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Completed suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 25.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 25.0 | View |
| Peptic ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 25.0 | View |
| Intervertebral disc degeneration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | View |
| Spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | View |
| Pleuritic pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | View |
| Arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 25.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 25.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 25.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 25.0 | View |
| Blood loss anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 25.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 25.0 | View |
| Abnormal uterine bleeding | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 25.0 | View |
| Pelvic organ prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 25.0 | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | View |
| Vertigo positional | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 25.0 | View |
| Systemic inflammatory response syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 25.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 25.0 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 25.0 | View |
| Astrovirus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 25.0 | View |
| Intervertebral discitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 25.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 25.0 | View |