Table 4.

Adverse events from extension study

	Prednisone Alone (N=33)	Thymectomy+ Prednisone (N=35)
Number of events through month 60 on TAC survey	37	29
Patients having ≥1 event through month 60 on TAC survey	14 (42)	12 (34)
Classification
Life threatening	5 (15)	1 (3)
Disability, Incapacity†	0 (0)	6 (17)
Required medical or surgical intervention	2 (6)	5 (14)
Death	0 (0)	0 (0)
Hospitalisations for all causes	16 (48)	5 (14)
Cumulative hospital days*	29.2 ± 22.3	26.0 ± 21.2
Hospitalisation by MEDRA codes
Gastrointestinal disorders	1 (3)	1 (3)
Hepatobiliary disorders	1 (3)	0 (0)
Infections and infestations	2 (6)	2 (6)
Injury, poisoning and procedure complications	0 (0)	1 (3)
Metabolism and nutrition disorders	0 (0)	1 (3)
Nervous system disorders	10 (30)	3 (9)
Respiratory, thoracic and mediastinal disorders	2 (6)	0 (0)
Surgical and medical procedures	2 (6)	0 (0)
Vascular disorders	1 (3)	0 (0)
Hospitalisation for MG exacerbation
Months 0–60: # of patients	10/33 (30)	2/35 (6)
cumulative days	26.4 ± 22.9	26.0 ± 21.2

Data are n (%) or mean (SD)

^†Disability/incapacity etiologies: for prednisone alone group, worsening swallowing difficulties and myasthenia gravis; in thymectomy+prednisone group, osteoporotic thoracic fracture, ocular muscle involvement due to relapsing MG, post-thymectomy diaphragmatic hemiparesis, rib fracture, impending myasthenic crisis, Pott’s fracture, tear of left knee meniscus, and low back pain with possible stenosis.

^*Only for those who had hospitalisation

MEDRA denotes medical dictionary for regulatory activities, MG myasthenia gravis; TAC treatment associated complications survey