Table 2. Adverse events.

	Grade 2		Grade 3		Grade 4		Grade 5
	Arm 1	Arm 2	Arm 1	Arm 2	Arm 1	Arm 2	Arm 1	Arm 2
General/Constitutional
Fatigue	3 (23%)	3 (23%)	1 (4%)
Weight loss		1 (4%)
Endocrine
Adrenal insufficiency				1 (4%)
Hyperthyroidism	1 (8%)	1 (8%)
Hypothyroidism	2 (15%)	2 (15%)
Gastrointestinal
Abdominal pain		1 (4%)
Constipation		1 (4%)
Diarrhea	1 (4%)			1 (4%)
GE reflux		1 (4%)
Hepatitis				1 (4%)
Nausea	1 (4%)
Pancreatitis				1 (4%)
Laboratory investigations
Increased ALT		1 (4%)
Increased AST	1 (4%)			1 (4%)
Increased alk phos		1 (4%)
Metabolism/Nutrition
Hyperglycemia		1 (4%)
Musculoskeletal
Arthralgia		1 (4%)
Back pain		1 (4%)
Nervous system
Syncope			1 (4%)
Reproductive system
Scrotal pain		1 (4%)
Vascular disorders
Hot flashes	1 (4%)
Multi-organ failure								1 (4%)

All adverse events by grade > grade 1 that were believed to be at least possibly related to treatment are shown. The numbers represent the number of patients (out of 22) experiencing a particular event at any point during the 3- to 6-month treatment period, with the highest grade reported for any single individual.