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Table 4 Neuropsychiatric assessment

From: Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer

Completion rate of PHQ-9 and GAD-7 scales by timepoint

PHQ-9

No. patients required

No. patients completed (% of required)

Baseline

50

49 (98)

 Cycle 1 day 15

45

44 (98)

 Cycle 2 day 1

40

38 (95)

 Cycle 2 day 15

26

26 (100)

 Cycle 3 day 1

19

15 (79)

 Off treatment

50

36 (72)

GAD-7

No. patients required

No. patients completed (% of required)

 Baseline

50

49 (98)

 Cycle 1 day 15

45

44 (98)

 Cycle 2 day 1

40

38 (95)

 Cycle 2 day 15

26

26 (100)

 Cycle 3 day 1

19

15 (79)

 Off treatment

50

36 (72)

Assessment

 

Overall (%)

Normal, n (%)

Grade 1, n (%)

Grade 2, n (%)

Grade 3, n (%)

PHQ-9

 Baseline

49

33 (67)

14 (29)

2 (4)

0 (0)

 Highest grade on study

50

11 (22)

24 (48)

11 (22)

4 (8)

GAD-7

 Baseline

49

33 (67)

14 (29)

2 (4)

0 (0)

 Highest grade on study

50

21 (42)

19 (38)

8 (16)

2 (4)

Change to medications for mood disorder

 

Total (n = 50), n (%)

No

- 45 (90)

Yes

- 5 (10)

  1. PHQ-9 and GAD-7 Score Severity CTCAE grading: 0–4 normal; 5–9 grade 1; 10–14 grade 2; ≥ 15 grade 3
  2. GAD-7 Generalized Anxiety Disorder Scale, PHQ-9 Patient Health Questionnaire-9