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: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT05938920
Description: An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
Study: NCT05938920
Study Brief: Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
INS018_055 30 mg QD Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral 0 None 2 18 13 18 View
INS018_055 30 mg BID Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral 1 None 4 18 15 18 View
INS018_055 60 mg QD Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral 0 None 7 18 15 18 View
Placebo Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral 0 None 3 17 12 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Carbohydrate antigen 19-9 increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Alpha hydroxybutyrate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Bile acids increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatine phosphokinase MB increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Carbon dioxide decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Carotid intima-media thickness increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram ST segment abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram high voltage SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Glutamate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Hepatic enzyme abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Immunoglobulins increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Interferon gamma level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
QRS axis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Reticulocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Throxine free decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Tri-iodothyronine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperchloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Eosinophilia myalgia syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Prostatic calcification SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View