Table 6.

Adverse event rate compared between STK inhibitor alone and STK inhibitor + cytotoxic agent regimens (clinical trial cohort).

	Grades 1–4				Grades 3 and 4
	All patients	STK alone	STK + cytotoxic agent		All patients	STK alone	STK + cytotoxic agent
Subject no.(n)	426	286	121	P value	426	286	121	P value
Blood/Lymphatic disorders	1.6	1.7	1.8	0.62	0.5	0.4	0.7	0.83
Cardiac disorders	0.1	0.1	<0.1		<0.1	0	0
Constitutional	0.3	0.5	<0.1		<0.1	0	0
Endocrine disorders	<0.1	<0.1	0		0	0	0
Eye disorders	<0.1	<0.1	<0.1		<0.1	0	0
Gastrointestinal disorders	1.4	1.3	1.7		0.2	0.1	0.3
General disorders/administration site conditions	0.5	0.4	0.8		0.1	0.1	0.2
Immune system disorder	<0.1	<0.1	<0.1		<0.1	0	0
Infections /Infestations	0.1	0.1	0.1		<0.1	<0.1	<0.1
Investigations	0.3	0.2	0.4		<0.1	<0.1	<0.1
Metabolism/Nutrition disorders	0.7	0.7	0.8		0.1	92 (0.1)	0.1
Musculoskeletal/Connective tissue disorders	0.1	0.1	0.1		<0.1	<0.1	<0.1
Neoplasms benign, malignant and unspecified	<0.1	<0.1	<0.1		<0.1	0	0
Nervous system disorders	0.3	0.3	0.3		<0.1	<0.1	0.1
Pain	0.3	0.3	0.1		<0.1	<0.1	<0.1
Renal/Urinary disorders	<0.1	<0.1	<0.1		<0.1	<0.1	0
Reproductive system/breast disorders	<0.1	<0.1	0		0	0	0
Respiratory, thoracic, and mediastinal disorders	0.1	0.2	0.1		<0.1	<0.1	0
Skin/Subcutaneous tissue disorders	0.7	0.7	0.8		0.1	0.1	0.2
Syndromes	<0.1	0	0		<0.1	<0.1	<0.1
Vascular disorders	0.1	<0.1	0.2		<0.1	<0.1	<0.1

Mann–Whitney U test for P values for comparison between STK inhibitor monotherapy versus STK inhibitor with chemotherapy. Rates of adverse events per patient were calculated by adding all patients experiencing adverse events in a particular organ system class and dividing by the total number of patients exposed to the drug regimen.

STK: Serine–threonine kinases.