Table 5 Adverse events of Lorlatinib in different studies.
EAP South Asia and US. Zhu V et al. [18] n = 76 | EAP Germany. Frost et al. [16] n = 37 | EAP France. Baldacci et al. [17] n = 208 | China. Lee et al. [19] n = 22 | This study n = 38 | |||||
|---|---|---|---|---|---|---|---|---|---|
G1–2 (%) | G3-5 (%) | G1 or 2 (%) | G3-5 (%) | G3-5 (%) | G1-2 (%) | G3-5 (%) | G1-2 (%) | G3-5 (%) | |
Any adverse event | - | - | 37 | 10 | 62 (30) | - | - | - | - |
Hypercholesterolemia | 58 (61) | 8 (8) | 15 (29) | 2 (4) | 24 (12) | 14 (74)* | 4 (18.8)* | 20 (53) | 5 (13) |
Hypertriglyceridemia | 41 (43) | 4 (4) | 5 (10) | 1 (2) | 8 (4) | - | - | 16 (42) | 4 (11) |
Edema | 7 (7) | 0 | 8 (16) | 2 (4) | 5 (2) | - | - | 13 (34) | - |
Cognitive disturbance | 6 (6) | 2 (2) | 5 (10) | 1 (2) | 11 (5) | - | - | 3 (8) | - |
Dizziness | 3 (3) | 0 | - | - | - | - | - | - | - |
Weight gain | 3 (3) | 0 | 1 (2) | 0 | - | - | - | 2 (5) | - |
Hallucinations | 2 (2) | 1 (1) | - | - | - | - | - | 3 (8) | - |
Rash | 2 (2) | 0 | 1 (2) | 0 | - | - | - | - | - |
Myalgia | 2 (2) | 0 | 1 (2) | 0 | - | - | - | 1 (3) | - |
Depression | 2 (2) | 0 | - | - | - | - | - | - | - |
ALT increased | 1 (1) | 1 (1) | - | - | - | - | - | 2 (6) | - |
Fatigue | 1 (1) | 0 | 2 (4) | 0 | 3 (1) | - | - | 4 (12) | - |
Blood bilirubin increased | 1 (1) | 0 | - | - | - | - | - | - | - |
CPK increased | 1 (1) | 0 | - | - | - | - | - | - | - |
Hemorrhoids | 1 (1) | 0 | - | - | - | - | - | - | - |
Dry eye | 1 (1) | 0 | - | - | - | - | - | - | - |
Blurred vision | 1 (1) | 0 | - | - | - | - | - | - | - |
Peripheral neuropathy | 1 (1) | 0 | 2 (4) | 0 | 5 (2) | - | - | 3 (8) | - |
Constipation | 1 (1) | 0 | - | - | - | - | - | - | - |
Pneumonitis | 0 | 1 (1) | 0 | 2 (4) | - | - | - | - | - |
Gait disturbance | 0 | 1 (1) | - | - | - | - | - | - | - |
Diarrhea | - | - | 3 (6) | 0 | - | - | - | 3 (8) | - |
Dysguesia | - | - | 2 (4) | 0 | - | - | - | - | - |
Lipase/Amylase increased | - | - | 3 (6) | 1 (2) | - | - | - | - | - |
Mucositis | - | - | 1 (2) | 0 | - | - | - | - | - |
Nausea | - | - | 1 (2) | 0 | - | - | - | 4 (11) | - |
Dyspnea | - | - | 5 (10) | 0 | - | - | - | - | - |
Pleural effusion | - | - | 0 | 1 (2) | - | - | - | - | - |
Pneumonia | - | - | 2 (4) | 0 | - | - | - | 2 (5) | 1 (3) |
Creatinine increased | - | - | 1‘(2) | 0 | - | - | - | 2 (5) | - |
Hypertension | - | - | 1 (2) | 0 | - | - | - | 2 (5) | - |
Hypothyroidism | - | - | 2 (2) | 0 | - | - | - | 4 (11) | - |
Thromboembolism | - | - | 1 (2) | 1 (2) | - | - | - | - | - |
Tongue swelling | - | - | 0 | 0 | - | - | - | - | - |
Pruritus | - | - | 1 (2) | 0 | - | - | - | - | - |
Sweating | - | - | 0 | 0 | - | - | - | - | - |
Ejection Fraction decrease | - | - | - | - | 4 (2) | - | - | - | - |
Mood effect | - | - | - | - | 3 (1) | - | - | - | - |
Arthralgia | - | - | - | - | 2 (1) | - | - | 2 (5) | - |
Pulmonary hypertension | - | - | - | - | 2 (1) | - | - | - | - |
Anemia | - | - | - | - | - | - | - | 11 (29) | 2 (5) |
Hyponatremia | - | - | - | - | - | - | - | 4 (11) | 1 (3) |
Hyperglycemia | - | - | - | - | - | - | - | 1 (3) | 1 (3) |
Hypokalemia | - | - | - | - | - | - | - | 1 (3) | - |
Hypophosphatemia | - | - | - | - | - | - | - | 1 (3) | - |
Hypomagnesemia | - | - | - | - | - | - | - | 4 (11) | - |
Hypoalbuminemia | - | - | - | - | - | - | - | 4 (11) | - |
Dyspepsia | - | - | - | - | - | - | - | 3 (8) | - |
Treatment Discontinuation due to toxicity | - | - | 5 | - | 14 (28) | - | 0 | 0 | - |
