Adverse event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
Depressed level of consciousness | Decreased level of alertness | Sedation; slow response to stimuli; limiting instrumental ADL* | Difficult to arouse | Life-threatening consequences; coma; urgent intervention indicated | Death |
Dysphasia | Awareness of receptive or expressive characteristics; not impairing ability to communicate | Moderate receptive or expressive characteristics; impairing ability to communicate spontaneously | Severe receptive or expressive characteristics; impairing ability to read, write, or communicate intelligibly | - | |
Edema cerebral | New onset; worsening from baseline | Life-threatening consequences; urgent intervention indicated | Death | ||
Encephalopathy | Mild symptoms | Moderate symptoms; limiting instrumental ADL* | Severe symptoms; limiting self-care ADL* | Life-threatening consequences; urgent intervention indicated | Death |
Headache | Mild pain | Moderate pain; limiting instrumental ADL* | Severe pain; limiting self-care ADL* | - | |
Paresthesia | Mild symptoms | Moderate symptoms; limiting instrumental ADL* | Severe symptoms; limiting self-care ADL* | - | |
Peripheral motor neuropathy | Asymptomatic; clinical or diagnostic observations only | Moderate symptoms; limiting instrumental ADL* | Severe symptoms; limiting self-care ADL* | Life-threatening consequences; urgent intervention indicated | Death |
Peripheral sensory neuropathy | Asymptomatic | Moderate symptoms; limiting instrumental ADL* | Severe symptoms; limiting self-care ADL* | Life-threatening consequences; urgent intervention indicated | - |
Seizure | Brief partial seizure and no loss of consciousness | Brief generalized seizure | New onset seizures (partial or generalized); multiple seizures despite medical intervention | Life-threatening consequences; prolonged repetitive seizures | Death |
Tremor | Mild symptoms | Moderate symptoms; limiting instrumental ADL* | Severe symptoms; limiting self-care ADL* | - |
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