CRS-related adverse reactions were predictable, manageable, and resolvable^1*

*“Predictable” refers to timing of CRS: Most CRS events occurred following the first full dose.²

^†Adverse reactions for TEPKINLY from clinical studies are listed by MedDRA system organ class and are based on the following convention: 

• very common (≥1/10); 
• common (≥1/100 to <1/10); 
• uncommon (≥1/1000 to <1/100); 
• rare (≥1/10,000 to <1/1000); 
• very rare (<1/10,000). 

^‡Actual EPCORE study start date: June 26, 2018. Estimated Primary Completion Date: January 2025.⁴

^aViral infection includes asymptomatic COVID-19, COVID-19, cytomegalovirus infection, cytomegalovirus infection reactivation, gastroenteritis viral, herpes simplex, herpes zoster, and oral herpes.

^bPneumonia includes COVID-19 pneumonia and pneumonia.

^cUpper respiratory tract infection includes laryngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, and upper respiratory tract infection.

^dFungal infection includes Candida infection, oesophageal candidiasis, and oral candidiasis.

^eSepsis includes bacteraemia, sepsis, and septic shock.

^fNeutropenia includes neutropenia and neutrophil count decreased.

^gAnaemia includes anaemia and serum ferritin decreased.

^hThrombocytopenia includes platelet count decreased and thrombocytopenia.

ⁱLymphopenia includes lymphocyte count decreased and lymphopenia.

^jCRS and ICANS adverse reactions were graded based on American Society for Transplantation and Cellular Therapy criteria.

^kTumour lysis syndrome was graded based on Cairo-Bishop criteria.

^lCardiac arrhythmias include bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia.

^mAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.

ⁿRash includes rash, rash erythematous, rash maculopapular, and rash pustular.

^oMusculoskeletal pain includes back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain, pain in extremity, and spinal pain.

^pFatigue includes asthenia, fatigue, and lethargy.

^qInjection site reactions include injection site bruising, injection site erythema, injection site hypertrophy, injection site inflammation, injection site mass, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling, and injection site urticaria.

^rPyrexia includes body temperature increased and pyrexia.

^sOedema includes face oedema, generalised oedema, oedema, oedema peripheral, and peripheral swelling.

^tBlood sodium decreased includes blood sodium decreased and hyponatraemia.