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 @ 3:07 PM
Ignite Modification Date: 2025-12-25 @ 1:28 PM
NCT ID: NCT01189292
Description: adverse events were recorded during the hospital stay
Frequency Threshold: 0
Time Frame: during hospitalisation (on average 2 days)
Study: NCT01189292
Study Brief: Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dexamethasone Injection Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery None None 0 76 8 76 View
Placebo (NaCl 0.9%) NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery None None 0 76 9 76 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
surgical adverse event grade I SYSTEMATIC_ASSESSMENT Surgical and medical procedures Clavien Dindo View
temporary hypoparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders Clavien Dindo View
bleeding requiring reoperation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
medical adverse events grade 1 SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Allergic reaction to metamizole SYSTEMATIC_ASSESSMENT Immune system disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View