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 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
NCT ID:
NCT01127451
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose of study drug up to approximately 1 year 6 months
Study:
NCT01127451
Study Brief:
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Denileukin Diftitox on Days 1 to 4 | Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease. | 22 | None | 15 | 43 | 43 | 43 | View |
| Denileukin Diftitox on Days 1, 8, and 15 | Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease. | 17 | None | 8 | 32 | 9 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endocarditis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Brain Oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Atrial Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Generalised Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Cancer Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Malignant Neoplasm Progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Metastases To Central Nervous System | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Metastatic Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Renal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Squamous Cell Carcinoma Of Skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Tumour Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Hypoventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 18.0 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |