Table 3. Baseline characteristics and Grades 3-5 adverse effects from randomized controlled trials.
Study | Study design | Number of patients in the crizotinib group | Number of patients in the corresponding group (different treatment or no treatment) | Percentage of patients affected by adverse effects of corresponding treatment (Grades 3–5) | Percentage of patients affected by adverse effects of crizotinib (Grades 3–5) | ||
Solomon et al. 2014 [11] | Randomized clinical trial | 171 | Chemotherapy: 169 | Vision disorders | 0 | Vision disorders | 1 |
Diarrhea | 1 | Diarrhea | 2 | ||||
Edema | 1 | Edema | 1 | ||||
Vomiting | 3 | Vomiting | 2 | ||||
Constipation | 0 | Constipation | 2 | ||||
Elevated ALT | 2 | Elevated ALT | 14 | ||||
Headache | 1 | Headache | 1 | ||||
Fatigue | 2 | Fatigue | 3 | ||||
Neutropenia | 15 | Neutropenia | 11 | ||||
Stomatitis | 1 | Stomatitis | 1 | ||||
Leukopenia | 5 | Leukopenia | 2 | ||||
Nausea | 2 | Nausea | 1 | ||||
Decreased appetite | 1 | Decreased appetite | 2 | ||||
Neuropathy | 0 | Neuropathy | 1 | ||||
Dyspnea | 2 | Dyspnea | 3 | ||||
Thrombocytopenia | 7 | Thrombocytopenia | 0 | ||||
Upper respiratory infection | 0 | Upper respiratory infection | 1 | ||||
Pyrexia | 1 | Pyrexia | 0 | ||||
Dizziness | 1 | Dizziness | 0 | ||||
Anemia | 9 | Anemia | 0 | ||||
Peters et al. 2017 [12] | Randomized clinical trial | 151 | Alectinib: 152 | Nausea | 1 | Nausea | 3 |
Diarrhea | 0 | Diarrhea | 2 | ||||
Vomiting | 0 | Vomiting | 3 | ||||
ALT increased | 5 | ALT increased | 15 | ||||
AST increased | 5 | AST increased | 11 | ||||
GGT increased | 1 | GGT increased | 1 | ||||
Edema | 0 | Edema | 1 | ||||
Anemia | 5 | Anemia | 1 | ||||
Camidge et al. 2018 [13] | Randomized clinical trial | 138 | Brigatinib: 137 | Diarrhea | 1 | Diarrhea | 2 |
Increase CK level | 16 | Increase CK level | 1 | ||||
Nausea | 1 | Nausea | 3 | ||||
Hypertension | 10 | Hypertension | 3 | ||||
Increased ALT | 1 | Increased ALT | 9 | ||||
Increased lipase level | 13 | Increased lipase level | 5 | ||||
Vomiting | 1 | Vomiting | 2 | ||||
Constipation | 0 | Constipation | 1 | ||||
Increased amylase level | 5 | Increased amylase level | 1 | ||||
Pruritis | 1 | Pruritis | 1 | ||||
Decreased appetite | 1 | Decreased appetite | 3 | ||||
Peripheral edema | 1 | Peripheral edema | 1 | ||||
Upper abdominal pain | 1 | Upper abdominal pain | 1 | ||||
Bradycardia | 1 | Bradycardia | 0 | ||||
Pain in the extremity | 0 | Pain in the extremity | 1 | ||||
Increase in creatinine levels | 0 | Increase in creatinine levels | 1 | ||||
Neutropenia | 0 | Neutropenia | 4 | ||||
Pleural effusion | 1 | Pleural effusion | 1 | ||||
Photopsia | 0 | Photopsia | 1 |