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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT00396032
Description: Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Frequency Threshold: 0
Time Frame: The AEs/SAEs were recorded through the completion of Visit 4.
Study: NCT00396032
Study Brief: A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tenecteplase For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase None None 1 74 12 74 View
Placebo For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase None None 5 75 11 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteraemia None Infections and infestations None View
Clostridium Difficile Colitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Sepsis None Infections and infestations None View
Hypoglycaemia None Metabolism and nutrition disorders None View
Convulsion None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper None Gastrointestinal disorders None View
Chills None General disorders None View
Catheter Site Pruritus None General disorders None View
Bacteraemia None Infections and infestations None View
Neck Pain None Musculoskeletal and connective tissue disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Gingival Bleeding None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Stomach Discomfort None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Catheter Related Complication None General disorders None View
Catheter Site Pain None General disorders None View
Catheter Thrombosis None General disorders None View
Chest Pain None General disorders None View
Feeling Cold None General disorders None View
Swelling None General disorders None View
Pyelonephritis None Infections and infestations None View
Thrombosis in Device None Injury, poisoning and procedural complications None View
Muscle Spasms None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Dysuria None Renal and urinary disorders None View
Dyspnoea None Renal and urinary disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Hypotension None Vascular disorders None View