Adverse Events Module

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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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT00274651
Description: Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Frequency Threshold: 5
Time Frame: Throughout study, up to 4 weeks after last drug administration
Study: NCT00274651
Study Brief: A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (CTCL, ITT Population) CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV None None 7 29 29 29 View
Arm B (PTCL, ITT Population) PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV None None 8 24 23 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Apraxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Implant site abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoparaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Muscle spams SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View