| Laboratory investigation |
Grade 0 |
Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Grade 5 |
| Creatinine |
None |
1.5 times upper limit of normal (ULN) |
> 1.5-3.0 times ULN |
> 3.0-6.0 times ULN |
> 6.0 times ULN |
Death |
| Cardiac arrhythmia |
None |
Intervention not indicated |
Non-urgent medical intervention indicated |
Symptomatic and incompletely controlled medically or controlled with a device (e.g., defibrillator) |
Life-threatening complications (e.g., shock, arrhythmia in association with heart failure, hypotension, syncope) |
Death |
| Seizure |
None |
- |
One brief, generalized seizure; seizure(s) well controlled by anticonvulsants or infrequent focal motor seizures not interfering with activities of daily living |
Seizure in which there is an altered level of consciousness; poorly controlled seizure disorder; with breakthrough generalized seizures despite medical treatment |
Seizure of any kind which is prolonged, repetitive or difficult to control (e.g., status epilepticus, intractable epilepsy) |
Death |
