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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT01678560
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Frequency Threshold: 5
Time Frame: Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study
Study: NCT01678560
Study Brief: Remote Monitoring in Obstructive Sleep Apnea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits 0 None 3 26 0 26 View
Wireless Care These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring 1 None 3 26 0 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Inpatient Psychiatric hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Wolf -Parkinson-White syndrome. Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalisation due to Dyspnea and Chest Pain on exertion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization of encephalopathic patient transitioned to comfort care NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization Elective Laparoscopic repair of incisional hernia NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization for Elective Laminectomy - Fusion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):