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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT04526704
Description: TEAEs observed in the Treatment Continuation Cohort and the Re-Treatment Period of the Treatment-free/Re-Treatment Cohort are reported. AEs from the Treatment-free Period of the Treatment-free/Re-Treatment Cohort were captured and are reported as well.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events were collected from baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months.
Study: NCT04526704
Study Brief: Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Continuation Cohort Previously-treated participants with TGCT who continued their current dose of pexidartinib treatment. 0 None 2 21 19 21 View
Re-Treatment Period of Treatment-Free/Re-Treatment Cohort Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose of completion of prior study (Re-Treatment Period). 0 None 0 3 3 3 View
Treatment-Free Period of Treatment-Free/Re-treatment Cohort Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and reported adverse events. 0 None 0 11 7 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Creutzfeldt-Jakob disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
Blood creatinine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA26 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA26 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA26 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA26 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA26 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA26 View
Hair colour changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA26 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA26 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA26 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA26 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA26 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA26 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Intevertebral disc protusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA26 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA26 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA26 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA26 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA26 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA26 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA26 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA26 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA26 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA26 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA26 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA26 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA26 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA26 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA26 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA26 View