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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT01357356
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: NCT01357356
Study Brief: Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
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 750 ng all participants received SER120 750 ng once daily None None 2 188 18 188 View
SER120 1000 ng all participants received SER120 1000 ng once daily None None 3 186 15 186 View
SER120 1500 ng all participants received SER120 1500 ng once daily None None 5 184 21 184 View
Placebo all participants received Placebo once daily None None 6 187 19 187 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
metastatic squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tongue neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Squamous cell carcinoma skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View