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 @ 11:08 PM
Ignite Modification Date: 2025-12-25 @ 8:40 PM
NCT ID: NCT03507569
Description: All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
Frequency Threshold: 0
Time Frame: From treatment initiation until 14 days after the last dose of study treatment.
Study: NCT03507569
Study Brief: Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RO7017773 - 15mg Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days. 0 None 0 2 2 2 View
RO7017773 - 30mg Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days. 0 None 0 1 0 1 View
RO7017773 - 75mg Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days. 0 None 0 2 1 2 View
RO7017773 - 375mg Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days. 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.0 View
Catheter site paraesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.0 View
Catheter site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.0 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.0 View