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: 2025-12-25 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT03866434
Description: None
Frequency Threshold: 5
Time Frame: From start of study drug administration up to follow-up (up to Day 18)
Study: NCT03866434
Study Brief: Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPD422 + Omeprazole Participants received 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2\*0.5 mg) capsule orally on Day 1 under fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Day 2 to Day 7, followed by 1 mg of Anagrelide under fasted state in combination with Omeprazole 40 mg on Day 8. 0 None 0 20 9 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View