Table 4.

Selected adverse reactions in patients with indolent NHL.

Adverse reactions by categorya		Result (N = 146)b
		Any grade, %	Grade 3 or higher, %
Adverse reactions (≥20% any grade or ≥5% Grade ≥3), excluding laboratory terms c
General	Fever	85	8
	Fatigue	49	0.7
	Chills	29	0
Immune system	CRS	84	8
Cardiac or vascular	Hypotension	51	4.1
	Tachycardia	44	1.4
	Arrhythmia	21	2.1
	Hypertension	13	6
Nervous system or psychiatric	Encephalopathy	50	16
	Headache	45	1.4
	Tremor	31	0.7
	Dizziness	20	0
	Delirium	16	5
Infections	Infections, pathogen unspecified	42	14
	Pneumonia	13	8
Blood and lymphatic system	Febrile neutropenia	41	19
Gastrointestinal	Nausea	40	0
	Diarrhea	29	0.7
	Constipation	28	0
	Vomiting	24	0.7
Musculoskeletal	Musculoskeletal pain	40	1.4
Metabolism and nutrition	Decreased appetite	26	1.4
Respiratory	Cough	25	0
	Hypoxia	23	8
New or worsening laboratory abnormalities (≥20% Grade 3 or 4) c
Hematologic	Neutrophil count decrease	98	92
	Platelet count decrease	79	35
	Hemoglobin decrease	81	30
	Lymphocyte count decrease	23	23
Chemistry	Phosphate decrease	79	25

Includes grouped preferred terms. Refer to prescribing information for definitions. Toxicities were graded using NCI CTCAE version 4.03.

Includes 4 patients with FL diagnosis at enrollment, who were identified as having transformed lymphoma or DLBCL on central pathology review. These patients were excluded from the efficacy analysis.

Baseline for adverse reactions and laboratory values was assessed immediately prior to axicabtagene ciloleucel infusion.

Abbreviations: DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; NCI, National Cancer Institute Common Terminology Criteria for Adverse Events; NHL, non-Hodgkin lymphoma.