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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT04375150
Description: This observational retrospective study retrieved data from electronic medical records and claims and the data existed as structured data or combination of existing structured and unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence safety data were not collected and reported.
Frequency Threshold: 0
Time Frame: For all-cause mortality: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.
Study: NCT04375150
Study Brief: Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Axitinib + Avelumab Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study. 11 None 0 0 0 0 View
Axitinib + Pembrolizumab Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study. 161 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):