Safety of Intravenous Immunoglobulin (Tegeline®), Administered at Home in Patients with Autoimmune Disease: Results of a French Study
Table 5
Adverse events (AEs) in hospital and at home according to System Organ Class (SOC) and Preferred Term (PT) (MedDRA classification) (safety population, ).
Hospital
Home
System Organ Class
AE (%)♠
patient (%)◆
AE (%)♠
patient (%)◆
Preferred Term
Total
24 (100)
15 (100)
45 (100)
17 (100)
Nervous system disorders
15 (62.5)
11 (73.3)
19 (42.2)
11 (64.7)
Headache
15
11
18
10
Drowsiness♣
0
0
1
1
Vascular disorders
2 (8.3)
2 (13.3)
9 (20.0)
5 (29.4)
Hypertension
2
2
8
4
Hypotension♣
0
0
1
1
General disorders and administration site condition
2 (8.3)
1 (6.7)
8 (17.8)
3 (17.6)
Asthenia♣
0
0
1
1
Chest pain♣
0
0
1
1
Shivering
1
1
1
1
Hyperthermia
1
1
1
1
Malaise (feeling of faintness)♣
0
0
1
1
Peripheral edema♣
0
0
1
1
Pyrexia♣
0
0
1
1
Inflammation♣
0
0
1
1
Musculoskeletal and connective tissue disorders
0 (0.0)
0 (0.0)
4 (8.9)
3 (17.6)
Arthralgia♣
0
0
1
1
Back pain
0
0
1
1
Musculoskeletal pain
0
0
1
1
Myalgia♣
0
0
1
1
Dysimmune system disorders
0 (0.0)
0 (0.0)
2 (4.4)
2 (11.8)
Anaphylaxis reaction♣
0
0
1
1
Drug hypersensibility♣
0
0
1
1
Intestinal disorders
4 (16.7)
2 (13.3)
1 (2.2)
1 (5.9)
Nausea
3
2
1
1
Vomiting
1
1
0
0
Chest, respiratory, and mediastinal disorders
0 (0.0)
0 (0.0)
1 (2.2)
1 (5.9)
Acute dyspnea♣
0
0
1
1
Skin and subcutaneous tissue disorders
1 (4.2)
1 (6.7)
1 (2.2)
1 (5.9)
Eczema
1
1
0
0
Erythematous rash♣
0
0
1
1
AE (%)♠: = number of AEs; (%) = /total number of AEs ( at hospital; at home); patient◆: = number of patients with an AE; (%) = /number of patients with an AE ( at hospital; at home). A patient could have many AEs during this study; ♣serious adverse event ().
