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: 2025-12-26 @ 11:00 AM
Ignite Modification Date: 2025-12-26 @ 11:00 AM
NCT ID: NCT03746106
Description: The safty population included all participants who received the drug. The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 should be used to assess and grade adverse event severity, including laboratory abnormalities judged to be clinically significant.
Frequency Threshold: 0
Time Frame: Two cycles (which were separated by a washout period of 5-14 days) and each cycle was three days in duration.
Study: NCT03746106
Study Brief: The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thiamine Alone Participants who received 5 mg thiamine in 500 mL of water in either the first or second cycle of the study. 0 None 0 7 0 7 View
Thiamine Co-administered With Trimethoprim Participants who received a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water in either the first or second cycle of the study. 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):