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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT02946918
Description: All 14 subjects were considered at risk for adverse events
Frequency Threshold: 0
Time Frame: 18 weeks (until completion of the study)
Study: NCT02946918
Study Brief: Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tablets Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes) Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps 0 None 0 6 4 6 View
Gelcaps Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes) Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps 0 None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View