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 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT01830205
Description: None
Frequency Threshold: 5
Time Frame: First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Study: NCT01830205
Study Brief: Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group-A Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline. None None 0 12 0 12 View
Mild/Moderate Renal Impairment Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline. None None 0 6 1 6 View
Mild/Severe Renal Impairment Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline. None None 0 6 1 6 View
End Stage Renal Disease Participants with end stage renal disease and had eGFR \<15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. None None 0 12 3 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View