Table 2 Safety and adverse events.

From: Phase 1 study of GSK3368715, a type I PRMT inhibitor, in patients with advanced solid tumors

Preferred term

GSK3368715 dose

50 mg

(n = 3)

100 mg

(n = 16)

200 mg

(n = 12)

Total

(N = 31)

Any AEa

3 (100)

15 (94)

12 (100)

30 (97)

>10% of participants, n (%)

 Nausea

2 (67)

3 (19)

4 (33)

9 (29)

 Anemia

1 (33)

6 (38)b

2 (17)

9 (29)

 Fatigue

1 (33)

6 (38)

1 (8)

8 (26)

 Diarrhea

1 (33)

5 (31)b

1 (8)

7 (23)

 Vomiting

2 (67)

2 (13)

3 (25)

7 (23)

 Pyrexia

1 (33)

5 (31)

0

6 (19)

 Pulmonary embolism

0

2 (13)c

3 (25)f

5 (16)

 Neutrophil count decreased

0

1 (6)d,e

3 (25)

4 (13)

 Dyspnea

1 (33)

2 (13)

1 (8)

4 (13)

GSK3368715-related AEs by maximum grade, n (%)

 Grade 3

   

4 (13)

  Aortic thrombosis

0

0

1 (8)b,g

 

  Deep vein thrombosis

0

0

1 (8)

 

  Atrial fibrillation

0

0

1 (8)g

 

  Neutrophil count decreased

0

1 (6)e

0

 

 Grade 4

   

2 (6)

  Platelet count decreased

0

0

1 (8)b,g

 

  Lymphocyte count decreased

0

0

1 (8)b

 
  1. AE adverse event.
  2. aIncludes all AEs and all grades.
  3. bLed to dose interruption in 1 participant.
  4. cLed to permanent discontinuation in 1 participant.
  5. dPossibly study drug related.
  6. eLed to a dose reduction.
  7. fFatal in 1 participant.
  8. gCategorized as dose-limiting toxicity.