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Table 2 Adverse events (safety population)

From: A randomized, placebo-controlled experimental medicine study of RIPK1 inhibitor GSK2982772 in patients with moderate to severe rheumatoid arthritis

 

Placebo b.i.d. (n = 3)

Placebo t.i.d. (n = 15)

Placebo total (n = 18)

GSK2982772 60 mg b.i.d. (n = 5)

GSK2982772 60 mg t.i.d. (n = 28)

GSK2982772 60 mg total (n = 33)

Any AE, n (%)

3 (100)

10 (67)

13 (72)

3 (60)

17 (61)

20 (61)

Any SAE, n (%)

0

0

0

0

2 (7)

2 (6)

 Eye disorder

  Retinal vein thrombosis

0

0

0

0

1 (4)

1 (3)

 Injury, poisoning and procedural complications

  Multiple fractures

0

0

0

0

1 (4)

1 (3)

Any AE leading to withdrawal, n (%)

0

0

0

0

3 (11)

3 (9)

 Infections and infestations

  Bronchitis

0

0

0

0

1 (4)

1 (3)

 Eye disorder

  Retinal vein thrombosis (SAE)

0

0

0

0

1 (4)

1 (3)

 Injury, poisoning, and procedural complications

  Multiple fractures (SAE)

0

0

0

0

1 (4)

1 (3)

Any treatment-related AEs, n (%)

3 (100)

2 (13)

5 (28)

1 (20)

6 (21)

7 (21)

 Severe

0

0

0

0

1 (4)

1 (3)

 Moderate

1 (33)

1 (7)

2 (11)

1 (20)

4 (14)

5 (15)

 Mild

2 (67)

1 (7)

3 (17)

0

1 (4)

1 (3)

AEs occurring in > 10% of combined groups, n (%)

 Musculoskeletal and connective tissue disorders

  Arthralgia

 

2 (11)

 

2 (6)

 Nervous system disorders

  Headache

 

2 (11)

 

1 (3)

 General disorders and administration site conditions

 

  Peripheral swellinga

 

2 (11)

 

0

  1. aIncluded swelling in the lower limbs and hands
  2. AE, adverse event; b.i.d., twice daily; SAE, serious adverse event; t.i.d., three times daily