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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT03137992
Description: Adverse events are illnesses or signs/symptoms that appear or worsen during the testing of a drug whether o not considered related to the investigational product (synonyms = medicinal or pharmaceutical product, study medication, clinical trial materials, etc.) including side effects, injury, toxicity, or hypersensitivity reactions. AEs were captured during participant interviews during on-site and telephonic visits.
Frequency Threshold: 1
Time Frame: All AEs/SAEs were assessed through study completion, an average of 14 weeks for participants enrolled in only part 1 of the study and 26 weeks for participants enrolled in part 1 and part 2 of the study. AEs were recorded starting after the patient signed the informed consent form and assessed at each visit.
Study: NCT03137992
Study Brief: Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product (Lupin Tiotropium Bromide Inhalation Powder) Single dose 18 mcg of test product (tiotropium bromide inhalation powder) for double blind portion. Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness). 0 None 0 337 0 337 View
Reference Product (Spiriva®) Single dose of reference product (Spiriva®) 18 mcg Reference Product (Spiriva®): Reference product (Spiriva®) 18 mcg. 0 None 0 343 0 343 View
Placebo Single dose of placebo inhalation powder Placebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers. 0 None 0 329 0 329 View
Serious Events(If Any):
Other Events(If Any):