Tolerability and safety of the intravenous immunoglobulin octagam^® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials

Figures & data

Table 1. Baseline demographics and treatment details of the subgroup of patients with ITP who received octagam^® 10% in post-authorisation safety studies.

Characteristic
Patients, n	112
Gender, n (%)
Male	55 (49.1%)
Female	57 (50.9%)
Mean age, years (range)	59.7 (21–92)
Total number of octagam^® 10% infusions	626
Median treatment interval, weeks (range)	3.2 (0.7–91.3)
Courses, n	297
Courses with >1 infusion, n (%)	124 (41.8)
Mean dose per infusion
g	26.5
g/kg of bodyweight	0.4
Mean dose per course, g/kg of bodyweight	0.9
Total octagam^® weight used, g	16,120

Note: ITP: immune thrombocytopenia.

Table 2. Number of ADR cases and events by MedDRA preferred term reported in the subgroup of 112 patients ITP who received octagam^® 10% in post-authorisation safety studies.

ADRs, n	Octagam^® infusions (n = 626)
Total cases^a	5
Mild	2
Moderate	2
Severe	0
No severity data	1
Total events	10
Nausea	1
Drug exposure during pregnancy	2
Back pain	3
Sensation of heaviness	1
Dizziness	1
Headache	2

Note: ITP: immune thrombocytopenia; MedDRA: Medical Dictionary for Regulatory Activities.

^aCases include all ADRs that were related to a single infusion.