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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT00963469
Description: The number of patients listed in the Adverse Event (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.
Frequency Threshold: 4
Time Frame: During the 4 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Study: NCT00963469
Study Brief: Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks None None 0 451 22 451 View
Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks None None 2 448 27 448 View
Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks None None 0 180 12 180 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MERCK CRISP Dict. View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MERCK CRISP Dict. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MERCK CRISP Dict. View