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 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
NCT ID:
NCT04529850
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
Study:
NCT04529850
Study Brief:
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Open Label Active Arm | 90mg GC4419 by IV Drug: GC4419: GC4419 60 Minute Infusion | 2 | None | 18 | 37 | 36 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa (23.0) | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa (23.0) | View |
| Stoma Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa (23.0) | View |
| COVID 19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa (23.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Leuokopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa (23.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa (23.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa (23.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa (23.0) | View |
| Tumor Haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa (23.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa (23.0) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa (23.0) | View |
| Hypomagnesamia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa (23.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa (23.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa (23.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa (23.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa (23.0) | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa (23.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa (23.0) | View |
| Radiation Skin Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa (23.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa (23.0) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa (23.0) | View |
| Oral Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa (23.0) | View |