A Pilot Study of Anti-CTLA4 Antibody Ipilimumab in Patients with Synovial Sarcoma

Table 2

Adverse events on study and reported relationship to study drug.

System organ class	Adverse event (preferred term)	Number of events	CTC severity scale					Relationship; to study drug*
			1	2	3	4	5	1	2	3	4	5
	Total numbers	51	25	17	9			18	14	11	8
Blood and lymphatic disorders		2			2				2
	Lymphopenia	2			2				2
Endocrine disorders		1		1					1
	Hyperglycemia	1		1					1
Gastrointestinal disorders		12	5	2	5				1	3	8
	Abdominal pain	1		1					1
	Diarrhea	4	2		2					1	3
	Gastritis	2	1	1							2
	Nausea	2	1		1						2
	Proctalgia	1	1							1
	Vomiting	2			2					1	1
General disorders and administration site reactions		1	1							1
	Fatigue	1	1							1
Hepatobiliary disorder		10	5	4	1				7	3
	Hyperbilirubinemia	10	5	4	1				7	3
Infections and infestations		1		1				1
	Bronchitis	1		1				1
Investigations		14	8	5	1			13		1
	Alanine aminotransferase	1	1					1
	Aspartate aminotransferase	2	2					2
	Blood creatinine	1	1					1
	Blood alkaline phosphatase	6	4	2				6
	Hemoglobin	1		1				1
	Platelet count	2		1	1			2
	White blood count	1		1						1
Metabolism and nutrition disorders		3	1	2					3
	Hypoalbuminemia	1		1					1
	Hypocalcemia	1	1						1
	Hypophosphatemia	1		1					1
Musculoskeletal and connective tissue disorders		2	2							2
	Muscular weakness	1	1							1
	Musculoskeletal chest pain	1	1							1
Respiratory, thoracic, and mediastinal disorders		3	1	2				3
	Chest pain	2	1	1				2
	Pleural effusion	1		1				1
Skin and subcutaneous disorders		2	2					1		1
	Dermatitis acneiform	1	1					1
	Exfoliative rash	1	1							1

*Relationship to study drug: 1: not related, 2: unlikely related, 3: possibly related, 4: probably related, and 5: definitely related.