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 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
NCT ID:
NCT01596335
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01596335
Study Brief:
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TA-650 | TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours. | None | None | 0 | 16 | 15 | 16 | View |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours. | None | None | 1 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Kawasaki disease | None | Vascular disorders | MedDRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | None | Infections and infestations | MedDRA 17.1 | View |
| Conjunctivitis | None | Infections and infestations | MedDRA 17.1 | View |
| Fungal skin infection | None | Infections and infestations | MedDRA 17.1 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 17.1 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 17.1 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 17.1 | View |
| Neuralgia | None | Nervous system disorders | MedDRA 17.1 | View |
| Ear pain | None | Ear and labyrinth disorders | MedDRA 17.1 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Respiratory depression | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Anal haemorrhage | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Decubitus ulcer | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Miliaria | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Skin erosion | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Renal tubular disorder | None | Renal and urinary disorders | MedDRA 17.1 | View |
| Disuse syndrome | None | General disorders | MedDRA 17.1 | View |
| Oedema peripheral | None | General disorders | MedDRA 17.1 | View |
| Pyrexia | None | General disorders | MedDRA 17.1 | View |
| Activated partial thromboplastin time prolonged | None | Investigations | MedDRA 17.1 | View |
| Blood cholesterol increased | None | Investigations | MedDRA 17.1 | View |
| Double stranded DNA antibody positive | None | Investigations | MedDRA 17.1 | View |
| Eosinophil count increased | None | Investigations | MedDRA 17.1 | View |
| Liver function test abnormal | None | Investigations | MedDRA 17.1 | View |
| Transaminases increased | None | Investigations | MedDRA 17.1 | View |
| White blood cells urine positive | None | Investigations | MedDRA 17.1 | View |
| Arthropod sting | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Skin injury | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |