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 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT05677893
Description: None
Frequency Threshold: 0
Time Frame: From start of treament on Day 1 to Day 28
Study: NCT05677893
Study Brief: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Drug, 0.6 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg mutiple doses of the investigational drug. 0 None 0 8 0 8 View
Investigational Drug, 1.2 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg mutiple doses of the investigational drug. 0 None 0 8 2 8 View
Placebo, Part B (MAD) Eligible participants will be assigned to multiple doses of the placebo. 0 None 0 4 0 4 View
Investigational Drug, 0.3 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 0.3 mg/kg single doses of the investigational drug. 0 None 0 6 3 6 View
Investigational Drug, 0.6 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 0.6 mg/kg single doses of the investigational drug. 0 None 0 6 0 6 View
Investigational Drug, 1.2 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 1.2 mg/kg single doses of the investigational drug. 0 None 0 6 0 6 View
Placebo, Part A (SAD) Eligible participants will be assigned to single doses of the placebo. 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Noninfective bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View