Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands Telephone Tel +31(0)88 781 6000 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union 14/09/2020 EMA/484057/2020 Human Medicines Division Important medical event terms list (MedDRA version 23.1) Primary SOC MedDRA Code PT Name SOC Name Comment Added in 23.1 Change This term fits the inclusion for an immune-mediated condition that is 10084828 Immune-mediated cytopenia Blood and lymphatic system disorders usually related to a drug. Similar PT Immune thrombocytopenia is already X included. In v23.0 this term was an LLT under the PT Bone marrow failure, which 10028584 Myelosuppression Blood and lymphatic system disorders X was included in the 23.0 IME list. This term fits the inclusion criteria as a relevant term for cardiac 10084280 Foetal cardiac arrest Cardiac disorders X arrhythmias. Similar PT Cardiac arrest is included in the IME list. In v23.0 this term was an LLT under the PT Cardiac valve replacement 10080073 Prosthetic cardiac valve stenosis Cardiac disorders X complication, which was included in the 23.0 IME list. Perinatal hepatitis C in pediatric patients may range from asymptomatic to fulminant hepatitis. Congenital hepatitis C infection can be associated with 10084252 Congenital hepatitis C infection Congenital, familial and genetic disorders X significant multi-organ damage which meets the criteria for inclusion in the IME list. Congenital viral hepatitis is a viral infection of the baby's liver which occurs when a pregnant woman infected with hepatitis virus passes the virus onto her unborn infant. This may lead to acute or chronic liver 10084251 Congenital viral hepatitis Congenital, familial and genetic disorders X disease, scarring and/or cancer of the liver. Congenital hepatitis C infection can be associated with significant organ damage which meets the criteria for inclusion in the IME list. New term for v23.1 which fits inclusion criteria; relevant forms of eye 10084571 Macular thickening Eye disorders disorders such as retinopathies, glaucoma, keratitis, and cataracts. X Related PT Retinal thickening is on the list as well. New term for v23.1 which fits inclusion criteria; relevant forms of eye disorders such as retinopathies, glaucoma, keratitis, and cataracts and 10084478 Post thrombotic retinopathy Eye disorders X furthermore, inclusion criteria; thromboses where significant compromise of organ function or other significant consequences could result. Cord colitis is a syndrome of antibiotic-responsive, culture-negative diarrhea occurring after cord-blood HSCT. Patients with the cord colitis 10084779 Cord colitis syndrome Gastrointestinal disorders X syndrome have persistent watery, nonbloody diarrhea that is often associated with weight loss and frequently requires hospitalization. Gastric infarction represents an area of necrosis in the stomach resulting 10084858 Gastric infarction Gastrointestinal disorders from obstruction of the local circulation. Like any infarction of a vital organ X this term should be added to the list. Ischemic conditions of vital organs constitute an inclusion criterium of the 10084861 Gastric ischaemia Gastrointestinal disorders list. Like other forms of gastrointestinal ischemia already included, this X term should be added to the list. Certain drugs, such as novel immune-oncology agents, appear to induce 10084296 Immune-mediated gastritis Gastrointestinal disorders an excessive liberation of immune mediators causing inflammation of the X gastric mucosa. #Classified as internal/staff contractors by the European Medicines Agency Although the natural history of Crohn's disease presenting in infancy is poorly defined, many reports describe a high morbidity and the need for 10084237 Neonatal Crohn's disease Gastrointestinal disorders X surgery and parenteral nutrition. As its homolog in the adult, the term should be added to the IME list. Splanchnic hypoperfusion is often the consequence of abdominal injury, 10084829 Splanchnic hypoperfusion Gastrointestinal disorders X sepsis or circulatory collapse/shock. 10084554 Subacute pancreatitis Gastrointestinal disorders Vital organ inflammatory processes should be added to the list. X As per third inclusion criteria for the IME list, obstructions of 10084247 Biliary obstruction Hepatobiliary disorders gastrointestinal, respiratory, hepatobiliary, genitourinary tracts, and ductal X systems of vital organs should be included. Flood syndrome consists in a spontaneous rupture of an umbilical hernia 10084797 Flood syndrome Hepatobiliary disorders as a rare complication of long-standing ascites and end-stage liver X disease, and implies prompt urgent surgical referral. Hepatic hypoperfusion causes hepatic ischemia or hypoxia and is characterized by elevation of hepatic enzymes either transient or 10084751 Hepatic hypoperfusion Hepatobiliary disorders X persistent because of hepatic cellular injury. Like other hypoperfusion or ischemic processes of vital organs, this term qualifies for the list. This is a form of cholestasis caused by dysregulation of the normal immune response, often due to drug use and of no clear autoimmune 10084765 Immune-mediated cholestasis Hepatobiliary disorders X origin. It can be a serious immune disorder which qualifies for inclusion in the list. New PT for v23.1 which fits criterion as an IME. Multisystem inflammatory syndrome in children, described in the literature as well as Kawasaki-like Multisystem inflammatory syndrome syndrome, is a relatively new condition in children reported in context of 10084767 Immune system disorders X in children COVID-19. Multisystem inflammatory syndrome in children presents in a number of ways and can have serious complications including multi-organ failure. PT Kawasaki's disease is on the list as well. Ocular surface stem cell transplant New term for v23.1 which fits the criterion as an IME. Related PT Corneal 10084816 Immune system disorders X rejection graft rejection like many other transplant rejections is included as well. Relevant infections of vital organs, such as encephalitis, should be added 10084824 Cryptococcal meningoencephalitis Infections and infestations X to the list. Relevant forms of bacteraemia, fungaemia, sepsis/septicaemia, and 10084453 Device related bacteraemia Infections and infestations X toxaemia conditions are an inclusion criterium for the list. Because systemic or disseminated infections describe an infection that 10084395 Disseminated varicella Infections and infestations has spread to multiple organs or tissues, frequently leading to organ X failure, this term should be added to the list. Because systemic or disseminated infections describe an infection that Disseminated varicella zoster virus 10084396 Infections and infestations has spread to multiple organs or tissues, frequently leading to organ X infection failure, this term should be added to the list. Perforations and ruptures of gastrointestinal, respiratory, hepatobiliary and 10084304 Diverticulitis intestinal perforated Infections and infestations X genitourinary tracts should be added to the list. Peritonitis are relevant infections which require hospitalization and can 10084697 Focal peritonitis Infections and infestations X evolve to life-threatening complications, such as bowel perforation. Abscesses, cellulitis or pus collections of clinical significance or affecting 10084121 Infected urinoma Infections and infestations vital organs should be added to the list, in which both PTs Infected X seroma and Haematoma infection are already included. Infections are responsible for a number of different types of vasculitis. Conversely, patients with vasculitis may develop infections, which 10084550 Infected vasculitis Infections and infestations X sometimes mimic relapse. Extended infections of the vascular compartment should be added to the list. #Classified as internal/staff contractors by the European Medicines Agency Laryngeal cryptococcosis is a rare condition which often presents in association with high-dose inhaled corticosteroid use. Laryngeal 10084258 Laryngeal cryptococcosis Infections and infestations X cryptococcosis, despite its rarity, is important as it may easily be confused with laryngeal malignancy, both macroscopically and histologically. Parapharyngeal space space infections are potentially life threatening 10084479 Parapharyngeal space infection Infections and infestations because of involvement of vital structures within the carotid sheath and a X tendency to bacteremic dissemination. Vascular aneurysms, dissection and rupture of important vessels and 10084179 Pseudoaneurysm infection Infections and infestations heart cavities and structures, as well as relevant forms of infection should X be in the list. Relevant forms of bacteraemia, fungaemia, sepsis/septicaemia, and 10084639 SARS-CoV-2 sepsis Infections and infestations X toxaemia conditions are an inclusion criterium for the list. Abscesses and cellulitis of clinical significance or affecting vital organs are 10084348 Scrotal cellulitis Infections and infestations X an inclusion criterium for the list. PT Coronary sinus injury was added in V 23.1. Coronary sinus injury is a rare but critical complication of cardiac surgery leading to coronary venous rupture or stenosis. It is usually related to coronary sinus 10084806 Coronary sinus injury Injury, poisoning and procedural complications X perfusion catheter placement for retrograde cardioplegia infusion. Inclusion in the IME list is in line with already included PTs