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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT03570658
Description: None
Frequency Threshold: 0
Time Frame: From the date of first administered dose through 28 days after the last administered dose.
Study: NCT03570658
Study Brief: A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese 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
SAD - Placebo Participants received placebo matched to RO7049389. 0 None 0 6 1 6 View
SAD RO7049389 - 400 mg Participants received a single 400 mg dose of RO7049389. 0 None 0 10 3 10 View
SAD RO7049389 - 600 mg Participants received a single 600 mg dose of RO7049389. 0 None 0 10 1 10 View
MAD RO7049389 - 400 mg Participants received 400 mg of RO7049389 every 12 hours for 14 days. 0 None 0 10 6 10 View
SAD RO7049389 - 200 mg Participants received a single 200 mg dose of RO7049389. 0 None 0 2 0 2 View
MAD - Placebo Participants received placebo matched to RO7049389 0 None 0 4 2 4 View
MAD RO7049389 - 200 mg Participants received 200 mg of RO7049389 every 12 hours for 14 days. 0 None 0 10 9 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophil percentage increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Urinary casts present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Bilirubin conjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Lip dry NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Eosinophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View