Table 7.
Adverse event rate per patient based on STK pathways (clinical trial cohort).
Grades 1–4 |
Grades 3 and 4 |
|||||||
---|---|---|---|---|---|---|---|---|
Aurora kinase |
mTOR-AKT-PI3K |
MAPK-MEK-Raf |
Aurora kinase |
mTOR-AKT-PI3K |
MAPK-MEK-Raf |
|||
Subject no. (n) | 65 | 75 | 286 | P value | 65 | 75 | 286 | P value |
Blood/Lymphatic disorders | 2.8 | 1.7 | 1.3 | 0.024 | 1.3 | <0.1 | 0.4 | 0.012 |
Cardiac disorders | 0 | <0.1 | 0.1 | 0 | <0.1 | <0.1 | ||
Constitutional | 0 | 0.6 | 0.3 | 0 | <0.1 | <0.1 | ||
Endocrine disorders | 0 | 0 | <0.1 | 0 | 0 | 0 | ||
Eye disorders | 0 | <0.1 | <0.1 | 0 | 0 | <0.1 | ||
Gastrointestinal disorders | 1.9 | 1.8 | 1.1 | 0.1 | 0.3 | 0.1 | ||
General disorders/administration site conditions | 0.8 | 0.3 | 0.5 | <0.1 | <0.1 | <0.1 | ||
Immune system disorder | 0 | <0.1 | <0.1 | 0 | 0 | <0.1 | ||
Infections and infestations | 0 | 0.1 | <0.1 | 0 | <0.1 | <0.1 | ||
Investigations | 0.7 | 0 | 0.2 | <0.1 | 0 | <0.1 | ||
Metabolism and nutrition disorders | 1.1 | 0.5 | 0.6 | <0.1 | 0.1 | 0.1 | ||
Musculoskeletal and connective tissue disorders | 0 | <0.1 | <0.1 | 0 | <0.1 | <0.1 | ||
Neoplasms benign, malignant, and unspecified | 0 | 0 | <0.1 | 0 | 0 | <0.1 | ||
Nervous system disorders | 0 | 0.2 | 0.3 | 0 | 0 | <0.1 | ||
Pain | 0 | 0.5 | 0.2 | 0 | 0.1 | <0.1 | ||
Renal and urinary disorders | 0 | <0.1 | <0.1 | 0 | <0.1 | <0.1 | ||
Reproductive system and breast disorders | 0 | <0.1 | <0.1 | 0 | 0 | 0 | ||
Respiratory, thoracic, and mediastinal disorders | 0 | 0.4 | <0.1 | 0 | <0.1 | <0.1 | ||
Skin/Subcutaneous tissue disorders | 0.4 | 0.5 | 0.9 | 0 | <0.1 | 0.2 | ||
Syndromes | 0 | 0 | <0.1 | 0 | 0 | <0.1 | ||
Vascular disorders | 0 | 0 | 0.2 | 0 | 0 | <0.1 |
Krsukal–Wallis test for P values (comparison across the three groups). 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; mTOR: mammalian target of rapamycin; AKT: protein kinase B; PI3K: phosphatidylinositol 3-kinase; MAPK: mitogen-activated protein kinase; MEK: mitogen-activated protein kinase kinase.