Adverse Events Module

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: 2025-12-25 @ 1:14 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT02468193
Description: AE description; Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 68.0 weeks.
Study: NCT02468193
Study Brief: Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Osilodrostat Patients in this arm took the study drug, osilodrostat. 0 None 4 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.1) View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (21.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Psychiatric symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.1) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.1) View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (21.1) View
Steroid withdrawal syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (21.1) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Primary biliary cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.1) View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.1) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.1) View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.1) View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.1) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Reactive psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.1) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.1) View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.1) View