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: 2025-12-25 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:15 PM
NCT ID: NCT03873493
Description: None
Frequency Threshold: 5
Time Frame: All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Study: NCT03873493
Study Brief: A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Venetoclax + Ibrutinib Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission. 10 None 8 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
ASPERGILLUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OROPHARYNGEAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
MALIGNANT PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
RENAL TUBULAR DISORDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
FACET JOINT SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MALIGNANT NEOPLASM PROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
EUTHANASIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
HYPOACUSIS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
MIDDLE EAR EFFUSION SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
ANDROGEN DEFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
EYE SWELLING SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GLOSSODYNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
MELAENA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
PANCREATIC STEATOSIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
TONGUE ERUPTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
CATHETER SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
COMPLICATION ASSOCIATED WITH DEVICE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
HYPERPLASTIC CHOLECYSTOPATHY SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ESCHERICHIA URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
FOLLICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PARVOVIRUS B19 INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RHINOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
TONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
WOUND SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
LYMPHOCYTE COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
MAGNETIC RESONANCE IMAGING HEAD ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
FOLATE DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPERPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
TUMOUR LYSIS SYNDROME SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
LIPOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
CEREBRAL ATROPHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
DEVICE FAILURE SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
BLADDER DIVERTICULUM SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
NASAL ULCER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
PETECHIAE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
SKIN LESION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
ARTERIOSCLEROSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View