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 @ 6:52 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT05236257
Description: As it was stated in the protocol of the study, this retrospective observational study used secondary data collection from a previous clinical trial (SCOUT study) and from eligible databases used to select external historical control cohorts. Therefore, no new AEs or adverse drug reactions occurred besides the ones already described during the conduct of the initial clinical trial.
Frequency Threshold: 0
Time Frame: up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control
Study: NCT05236257
Study Brief: A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Larotrectinib Pediatric patients (up to 21 years old) with Infantile fibrosarcoma (IFS) harboring an NTRK gene fusion who have been enrolled in the SCOUT study (Bayer Study ID: 20290; NCT02637687) and treated with larotrectinib. 1 None 1 51 0 51 View
External Controls External historical control patients treated with at least one chemotherapy-based regimen, pooled from the Institut Curie (CURIE) database (N=18) and the Cooperative Weichteilsarkom Studiengruppe (CWS) database (N=24). 3 None 3 42 0 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):