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 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
NCT ID:
NCT02588651
Description:
None
Frequency Threshold:
0
Time Frame:
All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Study:
NCT02588651
Study Brief:
A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases | 17 | None | 10 | 23 | 23 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE V5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE V5.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE V5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Infections and infestations - Other, specify - | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE V5.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE V5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V5.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE V5.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE V5.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE V5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE V5.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V5.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Upper gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V5.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Genital edema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V5.0 | View |
| Gynecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V5.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE V5.0 | View |
| Portal hypertension | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE V5.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE V5.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE V5.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V5.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Laryngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE V5.0 | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V5.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V5.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V5.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE V5.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE V5.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE V5.0 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V5.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE V5.0 | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V5.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE V5.0 | View |
| Urinary urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE V5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V5.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE V5.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V5.0 | View |