TABLE A4.
Summary of CNS AEs in the Lorlatinib Group
| Cluster Term | Lorlatinib (n = 149) | ||||
|---|---|---|---|---|---|
| Any Grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Any AEs, No. (%) | 63 (42) | 36 (24) | 18 (12) | 8 (5) | 1 (1) |
| Cognitive effectsa | 41 (28) | 25 (17) | 11 (7) | 5 (3) | 0 |
| Mood effectsb | 31 (21) | 17 (11) | 12 (8) | 2 (1) | 0 |
| Speech effectsc | 9 (6) | 6 (4) | 2 (1) | 1 (1) | 0 |
| Psychotic effectsd | 8 (5) | 5 (3) | 1 (1) | 1 (1) | 1 (1) |
Abbreviations: AE, adverse event; HLGT, High-Level Group Term; HLT, High-Level Term; MedDRA, Medical Dictionary for Regulatory Activities; NEC, not elsewhere classified; PT, preferred term; SMQ, Standardized MedDRA Queries.
Cognitive effects were any event from HLGT cognitive and attention disorders and disturbances, deliria (including confusion), or mental impairment disorders.
Mood effects were any event from HLGT anxiety disorders and symptoms, depressed mood disorders and disturbances, manic and bipolar mood disorders and disturbances, mood disorders and disturbances NEC, or personality disorders and disturbances in behavior.
Speech effects were any event from HLT speech and language abnormalities.
Psychotic effects were any event from SMQ narrow psychosis and psychotic disorders or PT of psychotic symptom.