Intravenous tocilizumab for the treatment of giant cell arteritis: a phase Ib dose-ranging pharmacokinetic bridging study

Table 4 Overview of AEs

	7 mg/kg IV (period 1), n = 24	6 mg/kg IV (period 2), n = 22	All patients (periods 1 and 2), N = 24
Patients with ≥ 1 AE, n (%)	19 (79.2)	9 (40.9)	22 (91.7)
Total no. of AEs, n	35	16	51
Total no. of deaths, n	0	0	0
Total no. of patients with ≥ 1 AE, n (%)
Leading to withdrawal from treatment	1 (4.2)	0	1 (4.2)
Leading to dose modification or interruption	3 (12.5)	0	3 (12.5)
Grade ≥ 3^a	2 (8.3)	0	2 (8.3)
Treatment related^b	6 (25.0)	1 (4.5)	7 (29.2)
Patients with ≥ 1 SAE, n (%)	3 (12.5)	1 (4.5)	4 (16.7)
Total no. of patients with ≥ 1 SAE, n (%)
Leading to withdrawal from treatment	0	0	0
Leading to dose modification or interruption	3 (12.5)	0	3 (12.5)
Treatment related^b	1 (4.2)	0	1 (4.2)
Total no. of patients with selected AEs, n (%)
Infections	13 (54.2)	6 (27.3)	16 (66.7)
Neutropenia	0	0	0
Thrombocytopenia	1 (4.2)	0	1 (4.2)
Total no. of patients with an AE of special interest, n (%)
Serious bleeding events	2 (8.3)	0	2 (8.3)
Serious infections	1 (4.2)	0	1 (4.2)
Anaphylactic reactions	0	0	0
Demyelinating disorders	0	0	0
Gastrointestinal perforations	0	0	0
Hypersensitivity reactions	0	0	0
Malignancies	0	0	0
Myocardial infarctions	0	0	0
Opportunistic infections	0	0	0
Serious hepatic events	0	0	0
Stroke	0	0	0

Investigator text for AEs encoded using MedDRA, version 23.1. Multiple occurrences of the same AE in 1 individual are counted only once except for the “Total no. of AEs” row, in which multiple occurrences of the same AE are counted separately
AE Adverse event, IV Intravenous, MedDRA Medical Dictionary for Regulatory Activities, SAE Serious adverse event
^aIncidence and severity of adverse events as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, were evaluated
^bAs determined by the investigator

ISSN: 1478-6362