Table 2.

Most common adverse events and important grade 3 and 4 toxicities reported during the double-blind phase of the trial as well as during the first 6 months of open-label treatment with tasquinimod

	TASQ double-blind (0–6 months) n = 134		TASQ open-label (7–12 months) n = 34		Placebo double-blind (0–6 months) n = 67		Cross-over patients n = 41
	Grades 1–4	Grades 3 and 4	Grades 1–4	Grades 3 and 4	Grades 1–4	Grades 3 and 4	Grades 1–4	Grades 3 and 4
Fatigue	39 (29%)	1 (1%)	5 (15%)		12 (18%)		5 (12%)	1(2%)
Nausea	36 (27%)	2 (1%)	2 (6%)		11 (16%)		9 (22%)	1(2%)
Constipation	34 (25%)	2 (1%)	3 (9%)		11 (16%)		3 (7%)
Back pain	32 (24%)	2 (1%)	4 (12%)	1(3%)	7 (10%)	2(3%)	6 (15%)	2(5%)
Decreased appetite	27 (20%)	1 (1%)	1 (3%)		5 (7%)		2 (5%)
Pain in extremity	25 (19%)	1 (1%)	5 (15%)		4 (6%)		4 (10%)	2(5%)
Flatulence	22 (16%)				7 (10%)		1 (2%)
Arthralgia	21 (16%)	2 (1%)	4 (12%)		5 (7%)		2 (5%)
Anemia	16 (12%)	4 (3%)	2 (6%)	2(6%)	4 (6%)	1(1%)	1 (2%)	1(2%)
Diarrhea	16 (12%)	1 (1%)	2 (6%)		9 (13%)		3 (7%)
Insomnia	16 (12%)				4 (6%)		1 (2%)
Weight decreased	16 (12%)	1 (1%)					3 (7%)	1(2%)
Abdominal pain	14 (10%)	1 (3%)			4 (6%)		1 (2%)
Vomiting	14 (10%)				5 (7%)		4 (10%)	1(2%)
Blood amylase increased	13 (10%)	1 (1%)	1 (3%)				1 (2%)
Lipase increased	13 (10%)	7 (5%)	2 (6%)	1(3%)
Myalgia	13 (10%)	1 (1%)	2 (6%)		3 (4%)		2 (5%)
Edema peripheral	13 (10%)		2 (6%)		4 (6%)		4 (10%)	1(2%)
Musculoskeletal pain	12 (9%)		2 (6%)		5 (7%)		2 (5%)
Cough	11 (8%)		2 (6%)		3 (4%)		1 (2%)
Dyspnea	11 (8%)	2 (1%)			2 (3%)		2 (5%)
Headache	11 (8%)		3 (9%)		7 (10%)		2 (5%)
Urinary tract infection	10 (7%)	2 (1%)	1 (3%)		4 (6%)
Deep vein thrombosis	5 (4%)	4 (3%)					1 (2%)
Myocardial infarction	1 (1%)	1 (1%)					1 (2%)	1(2%)