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 @ 3:10 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT02481505
Description: No SAEs and No subject discontinued for AEs
Frequency Threshold: 0
Time Frame: 7 days
Study: NCT02481505
Study Brief: Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3 mL Chloroprocaine HCl 1% Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route None None 0 15 15 15 View
4 mL Chloroprocaine HCl 1% Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route None None 0 15 13 15 View
5 mL Chloroprocaine HCl 1% Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route None None 0 15 13 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhoae SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View