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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT05906732
Description: None
Frequency Threshold: 5
Time Frame: Part 1 : Period 1 (Day 1 to Day 10) and Period 2 (Day 1 to Day 17). Part 2: 12 days
Study: NCT05906732
Study Brief: Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dofetilide Dofetilide 500 ug bid Day 1 and Day 2 0 None 0 30 0 30 View
Dofetilide + Low Dose LQT-1213 TID 0.25 mg/kg (Days 3 and 4) Dofetilide + Low dose LQT-1213 TID 0.25 mg/kg (Days 3 and 4) 0 None 0 29 0 29 View
Dofetilide + Mid Dose LQT-1213 TID 0.50 mg/kg (Days 5 and 6) Dofetilide + Mid dose LQT-1213 TID 0.50 mg/kg (Days 5 and 6) 0 None 0 29 2 29 View
Dofetilide + High Dose LQT-1213 0.70 mg/kg on (Days 7 and 8) Dofetilide + High Dose LQT-1213 0.70 mg/kg on (Days 7 and 8) 0 None 0 25 0 25 View
Dofetilide + Placebo Dofetilide + Placebo Day 3 to Day 8 0 None 0 29 4 29 View
LQT-1213 16 mg TID LQT-1213 16 mg TID Day 2 to Day 4 (48 mg Daily) 0 None 0 6 3 6 View
LQT-1213 7 mg TID LQT-1213 7 mg TID Day 2 to Day 4 (21 mg Daily) 0 None 0 6 1 6 View
Placebo Matching LQT-1213 16 mg TID Placebo matching LQT-1213 16 mg TID (Day 1) 0 None 0 6 1 6 View
Placebo Matching LQT-1213 7 mg TID Placebo matching LQT-1213 7 mg TID (Day 1) 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin tightness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin warm NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhinitis atrophic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Electrode site irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View