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Table 3 Frequent (> 5%) treatment-emergent adverse events (safety population)

From: TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study

AE category

Placebo (N = 25)

TLC599 12 mg (N = 26)

TLC599 18 mg (N = 24)

Any adverse event

17 (68%)

18 (69%)

20 (83%)

 Headache

4 (16%)

3 (12%)

6 (25%)

 Nasopharyngitis

3 (12%)

4 (15%)

1 (4%)

 Cortisol decreased

0

2 (8%)

6 (25%)

 Upper respiratory tract infection

2 (8%)

1 (4%)

4 (17%)

 Arthralgia

3 (12%)

1 (4%)

2 (8%)

 Glucocorticoid deficiency

0

3 (12%)

1 (4%)

 Bronchitis

3 (12%)

0

0

 Cough

0

0

2 (8%)

 Diarrhea

0

3 (12%)

0

 Dyspepsia

0

2 (8%)

0

 Lipase increased

2 (8%)

0

1 (4%)

 Toothache

1 (4%)

0

2 (8%)

 Urinary tract infection

1 (4%)

2 (8%)

0

 Chronic kidney disease

2 (8%)

0

0

 Injury

2 (8%)

0

0