Table 2. . Pregnancy cases of bosutinib exposure: abortions.

Setting	Age (years)	Starting bosutinib dose (mg/day)	Indication	Therapy duration† (months)	Action taken	Relationship to bosutinib exposure	Details
Exposure via the mother
Spontaneous report from a contactable physician received via a sales representative	–	300	–	–	–	A drug-event causal association cannot be ruled out	The patient became pregnant while on bosutinib for an unspecified condition. The patient’s pregnancy was aborted on an unspecified date at the patient’s request
Clinical trial	35	400	1st-line CML	∼24	Bosutinib permanently discontinued after elective abortion	Unrelated	The patient became pregnant while receiving bosutinib. The patient chose to have an elective abortion at week 5 due to her personal decision not to have more children Concomitant medication included oral bendroflumethiazide 2.5 mg q.d. and oral enalapril 10 mg q.d. for hypertension, oral loperamide hydrochloride 2 mg prn, oral clemastine fumarate 1 mg prn and oral desloratadine 5 mg prn
Clinical trial	34	500	1st-line CML	<1‡	Dose not changed	Unrelated	The patient was thought to have become pregnant prior to enrolling in the study. Upon examination on a date after the patient began bosutinib therapy, the patient’s physician reported a suspected spontaneous abortion of an ectopic pregnancy
Clinical trial	23	400	1st-line CML	∼23	Bosutinib permanently discontinued ∼7 weeks' gestational age	Unrelated	The patient became pregnant while receiving bosutinib. The outcome of the pregnancy was partial molar pregnancy requiring dilation and curettage Concomitant medication included diphenhydramine hydrochloride, acetylsalicylic acid, caffeine, paracetamol, salicylamide, ondansetron, sumatriptan and ferrous sulfate
Exposure via the father
Clinical trial	–	500	≥2nd-line CML	–	Bosutinib continued unchanged	Unrelated	The patient began taking bosutinib for CML in February 2009. On an unknown date in 2009, a pregnancy of the patient’s partner was confirmed. On June 20, 2009, an elective abortion was carried out
Clinical trial	35	500	≥2nd-line CML	∼22§	Bosutinib continued unchanged	Unrelated	The patient’s partner became pregnant ∼22 months after the patient began therapy. On December 18, 2009, the partner underwent a medical abortion of the pregnancy
Clinical trial	32	500	≥2nd-line leukemia (unspecified)	∼5	Bosutinib continued unchanged	Unrelated	The patient began taking bosutinib in August 2007. In January 2008, a pregnancy of the patient’s partner was confirmed. The partner experienced a spontaneous abortion in May 2008. Fetal biopsy revealed basal deciduitis with necrosis foci and bleeding
Clinical trial	39	400	1st-line CML	∼7	Bosutinib continued unchanged	Unrelated	The patient began taking bosutinib in April 2015 for CML. An unintended pregnancy of the patient’s partner was confirmed in December 2015. Three weeks later, the partner underwent an elective termination via curettage induced abortion Concomitant medication was prednicarbate
Clinical trial	26	400	1st-line CML	∼7	–	Unrelated	The patient began taking bosutinib for CML in August 2015. In February 2016, a pregnancy of the patient’s partner with a gestational age of 8 weeks was confirmed. A week later, the partner communicated to the patient that the fetus was not growing and an abortion of the pregnancy would be performed. No congenital abnormality was confirmed No concomitant medication

^†From start of treatment to discontinuation of bosutinib/pregnancy confirmation.

^‡At diagnosis of ectopic pregnancy.

^§At estimated date of conception.

CML: Chronic myeloid leukemia; prn: As needed; q.d.: Daily.