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 @ 12:41 PM
Ignite Modification Date: 2025-12-25 @ 12:13 PM
NCT ID: NCT03012061
Description: Intent-to-Treat Population was used to collect adverse events.
Frequency Threshold: 3
Time Frame: On-treatment serious adverse events and non-serious adverse events were collected up to 25 weeks.
Study: NCT03012061
Study Brief: Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in 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
Placebo QD Participants received placebo once daily (QD) via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Participants also received Fluticasone Furoate (FF) 100 micrograms (mcg) once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks. 0 None 5 143 39 143 View
UMEC 31.25 mcg QD Participants received UMEC 31.25 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks. 0 None 4 139 47 139 View
UMEC 62.5 mcg QD Participants received UMEC 62.5 mcg once daily via the ELLIPTA DPI for 24 weeks. Participants also received FF 100 mcg once daily as background therapy, in the morning from a separate ELLIPTA DPI for 24 weeks. 0 None 3 139 33 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (21.0) View
Transient Ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View