jPulmonary edema includes acute pulmonary edema and pulmonary edema. 

kThrombosis includes deep vein thrombosis, embolism, pulmonary embolism, thrombosis, vena cava thrombosis, and venous thrombosis. 

lRash includes rash, rash maculo-papular, rash papular and rash pruritic. 

mDermatitis includes dermatitis, dermatitis acneiform and dermatitis contact. 

nVisual impairment includes vision blurred and visual impairment. 

Additional important adverse reactions that did not meet the threshold criteria for inclusion in Table 5 were:  

Blood and lymphatic system disorders: disseminated intravascular coagulation (3%), pancytopenia (2%), histiocytosis hematophagic (1%)  

Cardiac Disorders: arrhythmiaa (6%)  

Gastrointestinal disorders: vomiting (9%), abdominal painb (9%), anal incontinence (1%)  

General disorders and administration site conditions: asthenia (7%), multiple organ dysfunction syndrome (3%)  

Infections and infestations:  fungal infectious disorders (9%), viral infectious disorders (9%), bacterial infectious disorders (9%)  

Musculoskeletal and connective tissue disorders: myalgia (7%), back pain (6%)  

Nervous System: peripheral neuropathyc (8%), motor dysfunctiond (6%), speech disordere (3%), seizuref (3%), ischemic cerebral infarction (1%), tremor (7%), ataxia (2%)  

Psychiatric disorders: anxiety (9%), deliriumg (6%), sleep disordersh (9%)  

Respiratory, thoracic, and mediastinal disorders: hypoxia (8%), oropharyngeal paini (8%), pleural effusion (5%) pulmonary edemaj (3%)  

Metabolism and nutrition disorders: fluid overload (3%), tumor lysis syndrome (1%)  

Vascular disorders: thrombosisk (7%), hypertension (2%), capillary leak syndrome (1%)  

Skin and subcutaneous tissue disorders: rashl (8%), dermatitism (4%)  

Eye disorders: visual impairmentn (7%)  

Laboratory Abnormalities 

Selected laboratory abnormalities worsening from baseline Grade 0-2 to Grade 3-4 are shown in Table 6. 

Table 6. Grade 3 or 4 Laboratory Abnormalities occurring in > 10% of Patients Following KYMRIAH Infusion in Adult r/r DLBCL Patients Based on CTCAEa N = 106 

aCTCAE = Common Terminology Criteria for Adverse Events version 4.03 

Laboratory Parameter Grade 3 or 4 (%) 

Hematology  

Lymphopenia 94 

Neutropenia 81 

Leukopenia 77 

Anemia 58 

Thrombocytopenia 54 

Biochemistry  

Hypophosphatemia 24 

Hypokalemia 12 

Hyponatremia 11 

6.2     Immunogenicity