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: 2025-12-24 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT01756456
Description: The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
Frequency Threshold: 1
Time Frame: Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
Study: NCT01756456
Study Brief: Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5_rhNGF20_Phase 2_treatment rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only 2 None 14 52 23 52 View
6_vehicle group_Phase 2_treatment Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only. 1 None 4 52 21 52 View
1_rhNGF10_Phase 1 rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only 0 None 3 7 3 7 View
2_rhNGF20_Phase 1 rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only 0 None 1 7 5 7 View
3_vehicle group_Phase 1 Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only 0 None 3 4 1 4 View
4_rhNGF10_Phase 2_treatment rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only 5 None 13 52 23 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Aortic rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Corneal graft rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Corneal endotheliitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Neurotrophic keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Bladder prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Corneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Herpes ophthalmic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Immunodeficiency SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Transplant failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Trigeminal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lacrimation decreased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal deposits SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abnormal sensation in eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal endotheliitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye allergy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eyelid pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lagophthalmos SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Macular fibrosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Meibomianitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Pseudopterygium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Retinal cyst SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal erosion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Neurotrophic keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastric polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Bladder prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Folate deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Keratitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Corneal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Corneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Helicobacter gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Herpes ophthalmic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Blister infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Herpes simplex ophtalmic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Herpes zoster ophtalmic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Aortic rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Diastolic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Corneal graft rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal lesion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eyelid margin crusting SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal decompensation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Ocular hyperemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Instillation site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Suture related complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Vital dye staining cornea present SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View