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: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-26 @ 10:59 AM
NCT ID: NCT04007406
Description: All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
Frequency Threshold: 2.0
Time Frame: Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
Study: NCT04007406
Study Brief: DP13 - A Phase II Study in Patients With Primary Aldosteronism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
4 mg DP13 Patients receiving low dose dexfadrostat phosphate daily for 8 weeks 0 None 0 10 4 10 View
8 mg DP13 Patients receiving middle dose dexfadrostat phosphate daily for 8 weeks 0 None 0 12 6 12 View
12 mg DP13 Patients receiving high dose dexfadrostat phosphate daily for 8 weeks 0 None 0 13 7 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Amylase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood lactate dehydrogenase increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure diastolic increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastroesophageal reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Amenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Polymenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower limb edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Gastric leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View