Table 3.

Adverse Events.^*

Variable	Prednisone Alone (N = 60)	Thymectomy plus Prednisone (N = 66)	P Value
No. of events	93	48	<0.001†
≥1 event — no. of patients (%)	33 (55)	25 (38)	0.05‡
Event
Life-threatening event — no. of patients (%)	7 (12)	1 (2)	0.03§
Disability or incapacity — no. of patients (%)¶	2 (3)	8 (12)	0.10
Event requiring medical or surgical intervention — no. of patients (%)	5 (8)	9 (14)	0.40
Death — no. of patients (%)	1 (2)	0	0.48
Complication due to thymectomy — no. of patients (%)	NA	1 (2)	—
Hospitalization — no. of patients (%)	31 (52)	15 (23)	<0.001‡
Hospitalization for exacerbation of myasthenia gravis — no. of patients (%)	22 (37)	6 (9)	<0.001‡
Cumulative no. of hospital days	19.2±24.5	8.4±8.6	0.09
Reason for hospitalization according to MedDRA term — no. (%)
Gastrointestinal disorder	2 (3)	2 (3)	1.00
Hepatobiliary disorder	1 (2)	0	0.48
Infection or infestation	7 (12)	4 (6)	0.35
Injury, poisoning, or procedure complication	0	2 (3)	0.50
Metabolism or nutrition disorder	0	1 (2)	1.00
Nervous system disorder	22 (37)	8 (12)	0.001‡
Respiratory, thoracic, or mediastinal disorder	2 (3)	1 (2)	0.60
Surgical or medical procedure	7 (12)	0	0.005§
Vascular disorder	1 (2)	0	0.48

^*Plus–minus values are means ±SD. MedDRA denotes Medical Dictionary for Regulatory Activities, and NA not applicable.

^†The P value is based on Poisson regression that included all 126 patients.

^‡The P value is based on a chi-square test that included all 126 patients.

^§The P value is based on Fisher’s exact test that included all 126 patients.

^¶Causes of disability or incapacity in the group that received prednisone alone included worsening swallowing difficulties and myasthenia gravis; causes in the thymectomy group included osteoporotic thoracic fracture, ocular-muscle involvement due to relapsing myasthenia gravis, post-thymectomy diaphragmatic hemiparesis, rib fracture, impending myasthenic crisis, ankle fracture, tear of left knee meniscus, and low back pain with possible stenosis.