Table 3.
TEAEs reported in > 20% of patients of any grade
| TEAEsa | Dose level 1 Momelotinib 100 mg QD n = 3 n (%) |
Dose level 2A Momelotinib 200 mg QD n = 3 n (%) |
Dose level 2B Momelotinib 100 mg BID n = 5 n (%) |
Total Any grade n = 11 n (%) |
Total Grades 3–4b n = 11 n (%) |
|---|---|---|---|---|---|
| Diarrhea | 1 (33.3) | 3 (100.0) | 3 (60.0) | 7 (63.6) | 1 (9.1)c |
| Dry skin | 2 (66.7) | 2 (66.7) | 3 (60.0) | 7 (63.6) | |
| Fatigue | 2 (66.7) | 2 (66.7) | 3 (60.0) | 7 (63.6) | |
| Decreased appetite | 2 (66.7) | 3 (100.0) | 2 (40.0) | 7 (63.6) | |
| Cough | 2 (66.7) | 1 (33.3) | 3 (60.0) | 6 (54.5) | |
| Paronychia | 1 (33.3) | 2 (66.7) | 3 (60.0) | 6 (54.5) | |
| Urinary tract infection | 0 | 2 (66.7) | 4 (80.0) | 6 (54.5) | |
| Nausea | 2 (66.7) | 1 (33.3) | 2 (40.0) | 5 (45.5) | |
| Alopecia | 1 (33.3) | 2 (66.7) | 2 (40.0) | 5 (45.5) | |
| Rash | 1 (33.3) | 2 (66.7) | 2 (40.0) | 5 (45.5) | 1 (9.1)d |
| Headache | 2 (66.7) | 1 (33.3) | 2 (40.0) | 5 (45.5) | |
| Abdominal pain | 0 | 2 (66.7) | 2 (40.0) | 4 (36.4) | 1 (9.1) |
| Gastroesophageal reflux disease | 1 (33.3) | 0 | 3 (60.0) | 4 (36.4) | |
| Dyspnea | 2 (66.7) | 1 (33.3) | 1 (20.0) | 4 (36.4) | 1 (9.1) |
| Epistaxis | 2 (66.7) | 1 (33.3) | 1 (20.0) | 4 (36.4) | |
| Nasal dryness | 1 (33.3) | 2 (66.7) | 1 (20.0) | 4 (36.4) | |
| Chest discomfort | 1 (33.3) | 2 (66.7) | 1 (20.0) | 4 (36.4) | |
| Upper respiratory tract infection | 1 (33.3) | 1 (33.3) | 2 (40.0) | 4 (36.4) | 1 (9.1)e |
| Muscle spasms | 0 | 2 (66.7) | 2 (40.0) | 4 (36.4) | |
| Dry eye | 2 (66.7) | 0 | 2 (40.0) | 4 (36.4) | |
| Vision blurred | 2 (66.7) | 1 (33.3) | 1 (20.0) | 4 (36.4) | |
| Dysgeusia | 0 | 2 (66.7) | 2 (40.0) | 4 (36.4) | |
| Constipation | 0 | 1 (33.3) | 2 (40.0) | 3 (27.3) | 1 (9.1) |
| Dry mouth | 0 | 2 (66.7) | 1 (20.0) | 3 (27.3) | |
| Vomiting | 1 (33.3) | 1 (33.3) | 1 (20.0) | 3 (27.3) | |
| Erythema | 1 (33.3) | 1 (33.3) | 1 (20.0) | 3 (27.3) | |
| Hypertrichosis | 1 (33.3) | 1 (33.3) | 1 (20.0) | 3 (27.3) | |
| Skin fissures | 1 (33.3) | 0 | 2 (40.0) | 3 (27.3) | |
| Hematuria | 1 (33.3) | 1 (33.3) | 1 (20.0) | 3 (27.3) | |
| Neutropenia | 0 | 1 (33.3) | 2 (40.0) | 3 (27.3) | 2 (18.1)c |
BID twice daily, DLT dose-limiting toxicity, QD once daily
aSeverity graded according to Common Terminology Criteria for Adverse Events version 4.03
bOnly 2 grade 4 events (neutropenia and sepsis). There was 1 grade 3 pneumonitis in dose level 2B not listed in the table
cDLTs (1 grade 3 diarrhea, 1 grade 4 neutropenia)
dThere was grade 3 follicular rash and grade 3 papular rash in 1 patient at dose level 2A
eThere was a grade 3 upper respiratory infection co-occurring with grade 3 kidney infection and grade 4 sepsis in 1 patient at dose level 2A. Grade 3 pneumonia was also reported