Table 3.
Nonhematologic TEAEs occurring in at least 15% of patients receiving parsaclisib monotherapy (safety population)
| Preferred term (MedDRA) | 20 mg* (N = 34), n (%) | All doses (N = 72), n (%) | ||||
|---|---|---|---|---|---|---|
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Any TEAE | 32 (94) | 14 (41) | 6 (18) | 68 (94) | 29 (40) | 12 (17) |
| Diarrhea/colitis† | 12 (35) | 3 (9) | 1 (3) | 26 (36) | 6 (8) | 1 (1) |
| Nausea | 9 (26) | 0 | 0 | 26 (36) | 0 | 0 |
| Fatigue | 10 (29) | 0 | 0 | 22 (31) | 0 | 0 |
| Rash‡ | 10 (29) | 3 (9) | 0 | 22 (31) | 4 (6) | 0 |
| Cough | 5 (15) | 0 | 0 | 17 (24) | 0 | 0 |
| Vomiting | 4 (12) | 0 | 0 | 17 (24) | 0 | 0 |
| Dizziness | 5 (15) | 0 | 0 | 13 (18) | 0 | 0 |
| Pyrexia | 7 (21) | 0 | 0 | 13 (18) | 1 (1) | 0 |
| Hypokalemia | 6 (18) | 1 (3) | 0 | 12 (17) | 1 (1) | 0 |
| Abdominal pain | 6 (18) | 1 (3) | 0 | 11 (15) | 1 (1) | 0 |
| Constipation | 3 (9) | 0 | 0 | 11 (15) | 0 | 0 |
| Decreased appetite | 6 (18) | 0 | 0 | 11 (15) | 0 | 0 |
| Night sweats | 6 (18) | 0 | 0 | 11 (15) | 0 | 0 |
| Pruritus | 7 (21) | 0 | 0 | 10 (14) | 0 | 0 |
| Back pain | 6 (18) | 0 | 0 | 9 (13) | 0 | 0 |
| Chills | 5 (15) | 0 | 0 | 9 (13) | 0 | 0 |
MedDRA, Medical Dictionary for Regulatory Activities.
*
Based on starting dose. Includes patients who received once-daily and once-weekly dosing.
†
Includes preferred terms of diarrhea, colitis, enterocolitis, gastrointestinal inflammation, colitis microscopic, and cytomegalovirus colitis.
‡
Includes preferred terms of dermatitis exfoliative, rash, rash erythematous, rash macular, rash maculopapular, rash pruritic, exfoliative rash, rash generalized, rash popular, and rash pustular.