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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT01499303
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01499303
Study Brief: Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
200mg BID 200mg Fostmatinib BID None None 12 47 44 47 View
100mg BID 100mg Fostmatinib BID None None 3 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PNEUMONIA None Infections and infestations None View
CELLULITIS None Infections and infestations None View
CLOSTRIDIUM DIFFICILE INFECTION None Infections and infestations None View
NEUTROPENIC SEPSIS None Infections and infestations None View
CARDIAC ARREST None Cardiac disorders None View
CARDIAC FAILURE CONGESTIVE None Cardiac disorders None View
SINUS TACHYCARDIA None Cardiac disorders None View
SUPRAVENTRICULAR TACHYCARDIA None Cardiac disorders None View
PYREXIA None General disorders None View
FATIGUE None General disorders None View
ANAEMIA None Blood and lymphatic system disorders None View
PANCYTOPENIA None Blood and lymphatic system disorders None View
HYPONATRAEMIA None Metabolism and nutrition disorders None View
BACK PAIN None Musculoskeletal and connective tissue disorders None View
CONVULSION None Nervous system disorders None View
SYNCOPE None Nervous system disorders None View
PNEUMONITIS None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA None Gastrointestinal disorders None View
CONSTIPATION None Gastrointestinal disorders None View
NAUSEA None Gastrointestinal disorders None View
VOMITING None Gastrointestinal disorders None View
FATIGUE None General disorders None View
PYREXIA None General disorders None View
ASPARTATE AMINOTRANSFERASE INCREASED None Investigations None View
BLOOD ALKALINE PHOSPHATASE INCREASED None Investigations None View
BLOOD CREATININE INCREASED None Investigations None View
ALANINE AMINOTRANSFERASE INCREASED None Investigations None View
BLOOD BILIRUBIN INCREASED None Investigations None View
ANAEMIA None Blood and lymphatic system disorders None View
THROMBOCYTOPENIA None Blood and lymphatic system disorders None View
NEUTROPENIA None Blood and lymphatic system disorders None View
DYSPNOEA None Respiratory, thoracic and mediastinal disorders None View
COUGH None Respiratory, thoracic and mediastinal disorders None View
HYPERTENSION None Vascular disorders None View
BACK PAIN None Musculoskeletal and connective tissue disorders None View
HEADACHE None Nervous system disorders None View
HYPONATRAEMIA None Metabolism and nutrition disorders None View
DECREASED APPETITE None Metabolism and nutrition disorders None View
ABDOMINAL PAIN None Gastrointestinal disorders None View
ABDOMINAL DISTENSION None Gastrointestinal disorders None View
DYSPEPSIA None Gastrointestinal disorders None View
OEDEMA PERIPHERAL None General disorders None View
ASTHENIA None General disorders None View
BLOOD LACTATE DEHYDROGENASE INCREASED None Investigations None View
WHITE BLOOD CELL COUNT DECREASED None Investigations None View
BLOOD UREA INCREASED None Investigations None View
NEUTROPHIL COUNT DECREASED None Investigations None View
HYPOTENSION None Vascular disorders None View
ARTHRALGIA None Musculoskeletal and connective tissue disorders None View
MYALGIA None Musculoskeletal and connective tissue disorders None View
SYNCOPE None Nervous system disorders None View
HYPOKALAEMIA None Metabolism and nutrition disorders None View
NIGHT SWEATS None Skin and subcutaneous tissue disorders None View
PNEUMONIA None Infections and infestations None View
ANXIETY None Psychiatric disorders None View
CONFUSIONAL STATE None Psychiatric disorders None View
RENAL FAILURE ACUTE None Renal and urinary disorders None View