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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT04669366
Description: Minimum criteria for reporting an adverse event (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.
Frequency Threshold: 0
Time Frame: All-cause mortality: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019); Index date was defined as the participant's first identified prescription date
Study: NCT04669366
Study Brief: Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries
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 Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively. 82 None 0 0 0 0 View
Sunitinib 4:2 Schedule Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively. 627 None 0 0 0 0 View
Sunitinib 2:1 Schedule Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively. 168 None 0 0 0 0 View
Sunitinib: Switched From 4:2 to 2:1 Schedule Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively. 53 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):