Table 2 TRAEs occurring in ≥10% of patients and grade ≥3 TRAEs in more than one patient

From: A small-molecule inverse agonist of PPARγ for advanced solid tumors: a phase 1 trial

Preferred term

30 mg (N = 17) n (%)

50 mg (N = 20) n (%)

70 mg (N = 13) n (%)

100 mg (N = 6) n (%)

Total (N = 56) n (%)

TRAE ≥10%

Grade ≥3 TRAE

TRAE ≥10%

Grade ≥3 TRAE

TRAE ≥10%

Grade ≥3 TRAE

TRAE ≥10%

Grade ≥3 TRAE

TRAE ≥10%

Grade ≥3 TRAE

At least one event

16 (94.1)

6 (35.3)

19 (95.0)

12 (60.0)

12 (92.3)

10 (76.9)

6 (100)

5 (83.3)

53 (94.6)

33 (58.9)

Platelet count decreased*

8 (47.1)

2 (11.8)

10 (50.0)

4 (20.0)

11 (84.6)

5 (38.5)

3 (50.0)

1 (16.7)

32 (57.1)

12 (21.4)

Fatigue*

7 (41.2)

10 (50.0)

4 (20.0)

6 (46.2)

1 (7.7)

4 (66.7)

1 (16.7)

27 (48.2)

6 (10.7)

Anemia

5 (29.4)

4 (23.5)

5 (20.0)

3 (15.0)

5 (38.5)

5 (38.5)

4 (66.7)

3 (50.0)

19 (33.9)

15 (26.8)

Hyperglycemia*

2 (11.8)

6 (30.0)

2 (10.0)

6 (46.2)

1 (7.7)

2 (33.3)

1 (16.7)

16 (28.6)

4 (7.1)

AST increased

3 (17.6)

2 (10.0)

6 (46.2)

2 (33.3)

13 (23.2)

Hypertriglyceridemia

4 (23.5)

5 (25.0)

2 (15.4)

2 (33.3)

13 (23.2)

Diarrhea

2 (11.8)

3 (15.0)

3 (23.1)

4 (66.7)

12 (21.4)

ALT increased

1 (5.9)

2 (10.0)

6 (46.2)

2 (33.3)

11 (19.6)

Decreased appetite

3 (17.6)

4 (20.0)

3 (23.1)

1 (16.7)

11 (19.6)

Dry eye

5 (29.4)

2 (10.0)

2 (15.4)

2 (33.3)

11 (19.6)

Nausea

2 (11.8)

2 (10.0)

2 (15.4)

2 (33.3)

8 (14.3)

Hypomagnesemia

2 (11.8)

2 (10.0)

2 (15.4)

1 (16.7)

7 (12.5)

Hypophosphatemia

3 (17.6)

3 (15.0)

0

1 (16.7)

7 (12.5)

Vomiting

2 (11.8)

3 (15.0)

1 (7.7)

1 (16.7)

7 (12.5)

GGT increased

1 (5.9)

0

3 (23.1)

2 (33.3)

6 (10.7)

Hypokalemia

1 (5.9)

2 (10.0)

0

3 (50.0)

6 (10.7)

  1. *The following combined terms are included in this presentation: platelet count decreased includes thrombocytopenia; fatigue includes malaise and asthenia; hyperglycemia includes diabetes
  2. AST, aspartate aminotransferase; ALT, alanine aminotransferase; GGT, gamma-glutamyl transferase.