Table 9 Incidence of gastrointestinal AEs and pancreatitis

From: European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia

Drug/Side effects in %	Nausea	Abdominal pain	Vomiting	Dyspepsia	Diarrhoea	Constipation	Pancreatitis
Imatinib
Trial: O'Brien et al.¹
Design: randomized trial, newly diagnosed CML CP patients
Planned dose: 400 mg daily. N=551
All grades	43.7	27.7	16.9	16.2	32.8	8.5	NR
Grades 3 and 4	0.7	2.4	1.5	0	1.8	0.7	NR
Trial: Druker et al.¹⁷⁴
Design: follow-up of IRIS
Planned dose: 400 mg daily. N=382
All grades	50	37	NR	NR	45	NR	NR
Trial: Deininger et al.¹⁷⁵
Design: randomized trial, newly diagnosed CML CP patients
Planned doses: 400 vs 800 mg daily. N=145
All grades, 400 vs 800 mg	50 vs 58	NR	15 vs 28	Anorexia: 15 vs 22	39 vs 56	NR	NR
Grades 3 and 4, 400 mg vs 800 mg	3 vs 3	NR	1 vs 0	0 vs 0	1 vs 6	NR	NR
Nilotinib
Trial: Kantarjian et al.¹⁰⁵
Design: single-arm phase 2 trial, imatinib resistant or intolerant CP CML patients
Planned dose: 400 mg twice daily. N=321
All grades	25	NR	13	NR	12	13	47^a
Grades 3 and 4	<1	NR	<1	NR	2	<1	18^a
Trial: Saglio et al.²
Design: randomized trial, 3 arms, newly diagnosed CML CP patients, imatinib vs nilotinib in two dose regimens
Planned doses: 300 mg (N=282) or 400 mg twice daily (N=281)
All grades, 300 mg vs 400 mg	11 vs 19	NR	5 vs 9	NR	8 vs 6	NR	24 vs 29^a 15 vs 18^b
Grades 3 and 4, 300 mg vs 400 mg	<1 vs 1	NR	0 vs 1	NR	1 vs 0	NR	6 vs 6^a <1 vs 1^b
Dasatinib
Trial: Kantarjian et al.⁴
Design: randomized trial, newly diagnosed CML CP patients, imatinib vs dasatinib
Planned dose: 100 mg once daily (N=258)
All grades	8	NR	5	NR	17	NR	NR
Grades 3 and 4	0	NR	0	NR	<1	NR	NR
Trial: Shah et al.¹⁰⁶
Design: randomized trial, CML CP patients with resistance, suboptimal response or intolerance to imatinib
Planned doses: 100 mg once daily vs 50 mg twice daily vs 140 mg once daily vs 70 mg twice daily (N=670)
All grades, 100 mg once daily vs 50 mg twice daily vs 140 mg once daily vs 70 mg twice daily	18 vs 20 vs 24 vs 29	12 vs 12 vs 13 vs 10	7 vs 10 vs 10 vs 13	5 vs 3 vs 10 vs 7	25 vs 31 vs 29 vs 27	9 vs 10 vs 3 vs 2	NR
Grades 3 and 4, 100 mg once daily vs 50 mg twice daily vs 140 mg once daily vs 70 mg twice daily	1 vs 1 vs 1 vs 1	1 vs 0 vs 1 vs 1	1 vs 1 vs 1 vs 0	0 vs 0 vs 0 vs 0	1 vs 2 vs 4 vs 4	1 vs 0 vs 0 vs 0	NR
Bosutinib
Trial: Khoury et al.¹⁰⁷
Design: phase 2 study in CML CP patients after imatinib and dasatinib and/or nilotinib failure
Planned doses: 500 mg once daily (N=118)
All grades	43	15 (upper abdominal pain 13%)	32	NR	81	NR	24^c
Grades 3 and 4	0	0	1	NR	8	NR	7^c
Trial: Cortes et al.²²
Design: randomized trial, newly diagnosed CML CP patients, imatinib vs bosutinib
Planned doses: 500 mg once daily (N=248)
All grades	31	11 (+ upper abdominal pain 12%)	32	NR	68	NR	38^a
Grades 3 and 4	1	1 (upper abdominal pain 0%)	3	NR	11	NR	9^a
Ponatinib
Trial: Cortes et al.¹³⁵
Design: phase 2 trial in Ph+ leukaemias (six different cohorts of CML and Ph+ ALL)
Planned doses: 45 mg once daily (N=449)
All grades	3–19 in different cohorts	10–27 in different cohorts	NR	NR	NR	5–20 in different cohorts	0–8 in different cohorts^d
Grades 3 and 4	0 to <1 in different cohorts	2–7 in different cohorts	NR	NR	NR	0–3 in different cohorts	0–6 in different cohorts^d

Abbreviations: ALL, acute lymphoblastic leukaemia; CML, chronic myeloid leukaemia; CP, chronic phase; NR, not reported. Side effects, grading according to NCI-CTC (Common Terminology Criteria for Adverse Events of the National Cancer Institute).
^aReported as elevated lipase.
^bReported as elevated amylase.
^cReported as elevated lipase, and reported to be present in 6% of cases at baseline.
^dIncreased lipase of any grade reported separately in 9–21% patients in different cohorts (21% in the largest cohort, CP CML, n=270), and of grade 3–4 in 6–13% patients in different cohorts (10% in the largest cohort, CP CML, n=270).

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Table 9 Incidence of gastrointestinal AEs and pancreatitis

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