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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT01900704
Description: Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Frequency Threshold: 4
Time Frame: None
Study: NCT01900704
Study Brief: Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SER120 1500 ng All participants received SER120 1500 ng once daily None None 4 264 30 264 View
Placebo All participants received Placebo once daily None None 5 267 30 267 View
SER120 750 ng All participants received SER120 750 ng once daily None None 7 266 30 266 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gallbladder empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Salivary gland cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View