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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT02716818
Description: Adverse event information was collected at each visit by the investigator and reported accordingly.
Frequency Threshold: 0
Time Frame: Adverse event information was collected from the point of enrolment to completion of the study (6 months).
Study: NCT02716818
Study Brief: Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chronocort® Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subjects previous glucocorticoid therapy dose and then dose titrated to effect. Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol. 0 None 7 61 59 61 View
Standard Glucocorticoid Therapy Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of: 1. Hydrocortisone only 2. Prednisone or prednisolone, alone or in combination with hydrocortisone 3. Dexamethasone, alone or in combination with any other glucocorticoid 0 None 5 61 48 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Salpingitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Tonsilitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Adrenocortical Insufficiency (acute) SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Conjunctivitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Ear infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Tonsilitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Diarrhoea Infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral Rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Abnormal Loss of Weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Abnormal Weight Gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Fluid Retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Gluten Sensitivity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperinsulinaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Impaired Fasting Glucose NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Increased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Weight Fluctuation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Alcohol Intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Affect Lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Burnout Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Libido Decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Emotional Distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Circardian Rhythm Sleep Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness Postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Peripheral Nerve Lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Poor Quality Sleep SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Sensory Loss SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Psychomotor Hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Tension Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Foreign Body Sensation in Eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Ear Deformity Acquired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Tympanic Membrane Perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Vertigo Positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Epigastric Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscle Tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood Sodium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Body Temperature Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Osteocalcin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Renin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Mineralocorticoid Deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Faeces Soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Cold Sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Hair Growth Abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Chloasma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Joint Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscle Fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Menstruation Irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Fat Tissue Increased SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Influenza-like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Therapeutic Response Unexpected SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Sensation of Foreign Body SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Urine Output Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
C-Telopeptide Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Haematocrit Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Liver Function Test Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Head Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Auricular Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Ear Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Procedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Toxicity to Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Salpingitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diverticulum Intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View