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 @ 5:58 PM
Ignite Modification Date: 2025-12-25 @ 3:21 PM
NCT ID: NCT04044768
Description: Adverse events are reported for all participants who received afamitresgene autoleucel
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years).
Study: NCT04044768
Study Brief: Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MRCLS Eligible participants with metastatic or inoperable (advanced) MRCLS received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) 7 None 3 8 8 8 View
Synovial Sarcoma Eligible participants with metastatic or inoperable (advanced) synovial sarcoma received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) 24 None 23 44 44 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v 23 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v 23 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v 23 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v 23 View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v 23 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MEDDRA v 23 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Influenza-like illness SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Respiratory complication associated with device SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v 23 View
Lymphoproliferative disorder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v 23 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v 23 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v 23 View
Superior vena cava occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v 23 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v 23 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v 23 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA v 23 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v 23 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Chills SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v 23 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA v 23 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MEDDRA v 23 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v 23 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v 23 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v 23 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v 23 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v 23 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v 23 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v 23 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v 23 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v 23 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v 23 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v 23 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v 23 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v 23 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v 23 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v 23 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v 23 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA v 23 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v 23 View