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 @ 3:28 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT01641692
Description: On-treatment SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received at least one dose of randomized study medication during treatment period. Provision was made for the collection of any SAEs during the 9 - 14 days screening (pre-treatment) period. None was reported.
Frequency Threshold: 3
Time Frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to Study Day 70).
Study: NCT01641692
Study Brief: A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UMEC 250 µg QD Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. None None 1 135 12 135 View
UMEC 15.6 µg BID Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days. None None 0 126 7 126 View
UMEC 31.25 µg BID Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days. None None 0 133 7 133 View
UMEC 15.6 µg QD Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. None None 0 131 7 131 View
UMEC 31.5 µg QD Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. None None 0 138 7 138 View
UMEC 62.5 µg QD Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. None None 0 133 12 133 View
Placebo Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days. None None 0 126 4 126 View
UMEC 125 µg QD Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days. None None 0 128 11 128 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spontaneous abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Product taste abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA View