Table 3.

Adverse events reported with axicabtagene compared to tisagenlecleucel in EudraVigilance and FAERS and Reporting Odds Ratio (ROR)

EUDRAVIGILANCE
Events	N axicabtagene	N tisagenleucleucel	ROR	CI_low	CI_up
Aphasia	44	3	8.97	3.47	23.22
Tremor	41	3	8.35	3.19	21.84
CART-cell-related encephalopathy syndrome	53	4	8.13	3.80	17.40
Atrialfibrillation	16	2	4.84	1.11	21.11
Thrombocytopenia	30	4	4.56	1.95	10.67
Encephalopathy	94	15	3.88	2.78	5.42
Neurotoxicity	247	43	3.71	3.13	4.41
Somnolence	28	5	3.40	1.58	7.30
Disorientation	18	4	2.72	1.05	7.07
Cytokinereleasesyndrome	498	137	2.47	2.22	2.74
Malaise	24	6	2.42	1.17	5.02
Confusionalstate	43	11	2.38	1.47	3.84
Neutropenia	43	11	2.38	1.47	3.84
Tachycardia	63	17	2.26	1.57	3.26
Fatigue	38	14	1.64	1.04	2.61
Pyrexia	187	90	1.27	1.08	1.50
FAERS
Events	N axicabtagene	N tisagenleucleucel	ROR	CI_low	CI_up
Aphasia	66	3	15.82	6.46	38.77
Car T-Cell-Related Encephalopathy Syndrome	41	3	9.75	3.73	25.49
Atrial Fibrillation	26	2	9.24	2.36	36.20
Thrombocytopenia	36	5	5.13	2.49	10.53
Encephalopathy	110	16	4.99	3.65	6.80
Disorientation	28	4	4.97	2.10	11.77
Hyponatraemia	14	2	4.96	1.10	22.33
Incontinence	14	2	4.96	1.10	22.33
Tremor	54	9	4.29	2.64	6.97
Transaminases Increased	17	3	4.01	1.30	12.43
Neurotoxicity	312	60	3.96	3.42	4.57
Somnolence	41	8	3.65	2.10	6.34
Neutropenia	57	17	2.39	1.64	3.48
Agitation	20	6	2.36	1.10	5.08
Confusional State	58	18	2.30	1.59	3.32
Mental Status Changes	26	9	2.05	1.12	3.74
Disease Progression	26	9	2.05	1.12	3.74
Cytokine Release Syndrome	462	185	1.89	1.70	2.10
Tachycardia	63	31	1.44	1.06	1.97
Pyrexia	204	124	1.17	1.00	1.37

N number of reports, ROR reporting odds ratio, CI_low lower bound of the 95% confidence interval, CI_up upper bound of the 95% confidence interval