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 |
| 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.