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 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
NCT ID:
NCT01227551
Description:
Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Frequency Threshold:
5
Time Frame:
1 year
Study:
NCT01227551
Study Brief:
A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM )
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CVA21 | CVA21 monotherapy | None | None | 11 | 57 | 54 | 57 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 16.0 | View |
| cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, Version 16.0 | View |
| cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, Version 16.0 | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 16.0 | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 16.0 | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 16.0 | View |
| metastatic malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 16.0 | View |
| renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 16.0 | View |
| haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 16.0 | View |
| motor dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 16.0 | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 16.0 | View |
| iron deficiency | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, Version 16.0 | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, Version 16.0 | View |
| influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site discharge | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, Version 16.0 | View |
| rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 16.0 | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, Version 16.0 | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, Version 16.0 | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 16.0 | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 16.0 | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 16.0 | View |
| neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 16.0 | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, Version 16.0 | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 16.0 | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, Version 16.0 | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, Version 16.0 | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 16.0 | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 16.0 | View |
| oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 16.0 | View |
| sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 16.0 | View |
| hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 16.0 | View |
| pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 16.0 | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, Version 16.0 | View |