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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02296892
Description: Total number of participants affected with Other (Not Including Serious) Adverse Events represents any participant in the trial with a TEAE. The number of participants with Preferred Term (PT)TEAEs represents participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
Frequency Threshold: 5
Time Frame: Treatment-emergent Adverse Events were collected from Day 1 until end of Follow-Up (Day 4 [+3/-1 days]). TEAEs were followed-up until events were resolved, became stable or could be explained by another known cause(s)
Study: NCT02296892
Study Brief: A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Remimazolam Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance. 0 None 17 303 268 303 View
Placebo Placebo iv as inactive control arm 0 None 4 59 52 59 View
Midazolam Midazolam iv 1.75 mg\* for sedation induction and 1.0 mg\* for sedation maintenance. \*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill. 0 None 0 69 63 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Diastolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Systolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Diastolic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View