Table 3.
Most common any-grade TEAEs (occurring in ≥10% of patients in the total population) and grade ≥3 TEAEs among patients receiving parsaclisib (cohort 2)
| Preferred term (MedDRA), n (%) | WG (n = 28) |
DG (n = 72) |
All treated patients (N = 100) |
|||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any TEAE | 26 (92.9) | 11 (39.3) | 70 (97.2) | 52 (72.2) | 96 (96.0) | 63 (63.0) |
| Diarrhea∗ | 9 (32.1) | 1 (3.6) | 38 (52.8) | 11 (15.3) | 47 (47.0) | 12 (12.0) |
| Cough | 4 (14.3) | 0 | 19 (26.4) | 1 (1.4) | 23 (23.0) | 1 (1.0) |
| Rash | 5 (17.9) | 0 | 13 (18.1) | 2 (2.8) | 18 (18.0) | 2 (2.0) |
| Anemia | 3 (10.7) | 0 | 12 (16.7) | 6 (8.3) | 15 (15.0) | 6 (6.0) |
| Nausea | 3 (10.7) | 0 | 12 (16.7) | 0 | 15 (15.0) | 0 |
| Pruritus | 5 (17.9) | 0 | 10 (13.9) | 0 | 15 (15.0) | 0 |
| Pyrexia | 4 (14.3) | 0 | 11 (15.3) | 1 (1.4) | 15 (15.0) | 1 (1.0) |
| Fatigue | 3 (10.7) | 0 | 11 (15.3) | 1 (1.4) | 14 (14.0) | 1 (1.0) |
| Constipation | 2 (7.1) | 0 | 11 (15.3) | 0 | 13 (13.0) | 0 |
| Decreased appetite | 2 (7.1) | 0 | 11 (15.3) | 0 | 13 (13.0) | 0 |
| Headache | 3 (10.7) | 0 | 10 (13.9) | 0 | 13 (13.0) | 0 |
| Neutropenia | 3 (10.7) | 1 (3.6) | 10 (13.9) | 8 (11.1) | 13 (13.0) | 9 (9.0) |
| URTI | 0 | 0 | 13 (18.1) | 2 (2.8) | 13 (13.0) | 2 (2.0) |
| Abdominal pain | 1 (3.6) | 0 | 11 (15.3) | 3 (4.2) | 12 (12.0) | 3 (3.0) |
| Arthralgia | 4 (14.3) | 0 | 8 (11.1) | 2 (2.8) | 10 (10.0) | 2 (2.0) |
| Colitis | 0 | 0 | 10 (13.9) | 7 (9.7) | 10 (10.0) | 7 (7.0) |
| Dizziness | 2 (7.1) | 0 | 8 (11.1) | 0 | 10 (10.0) | 0 |
| Peripheral edema | 2 (7.1) | 0 | 8 (11.1) | 0 | 10 (10.0) | 0 |
| Pneumonia | 2 (7.1) | 2 (7.1) | 8 (11.1) | 7 (9.7) | 10 (10.0) | 9 (9.0) |
| UTI | 3 (10.7) | 0 | 7 (9.7) | 1 (1.4) | 10 (10.0) | 1 (1.0) |
MedDRA, Medical Dictionary for Regulatory Activities; URTI, upper respiratory tract infection; UTI, urinary tract infection.
∗
Time to onset of diarrhea (months): weekly dosing 3.6 (range, 1.05-10.8); daily dosing 2.6 (range, 0.03-23.85); all treated patients 2.7 (range, 0.03-23.85).