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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT04023994
Description: None
Frequency Threshold: 5
Time Frame: Up to approximately 9 weeks
Study: NCT04023994
Study Brief: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 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
Placebo In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. 0 None 0 10 8 10 View
RO7126209 (0.1 mg/kg) Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg). 0 None 0 4 3 4 View
RO7126209 (0.4 mg/kg) Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg). 0 None 0 4 2 4 View
RO7126209 (1.2 mg/kg) Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). 0 None 0 6 5 6 View
RO7126209 (3.6 mg/kg) Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). 0 None 0 6 6 6 View
RO7126209 (7.2 mg/kg) Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). 0 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Crepitations SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Injection site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View