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 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:55 PM
NCT ID: NCT00942903
Description: Adverse events were assessed during the three weeks the patients used the HME's, upon notification of a problem by the patient, and when the patient returned for a visit. When patients start using a new type of HME, they may need to adjust and may perceive an increased breathing resistance. This was not considered an adverse event.
Frequency Threshold: 5
Time Frame: Adverse events were monitored during the three weeks of the study
Study: NCT00942903
Study Brief: Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Provox XtraHME A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks None None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):