Data based on the Case Report Form
Items | Visit | ||
1 | 2 | 3 | |
0 day | 30±2 days | 210±5 days | |
Medical history | |||
Inclusion/exclusion criteria | √ | ||
ICF | √ | ||
Symptom differentiation | √ | ||
General information | √ | ||
History of medical treatments and allergies | √ | ||
Current medications | √ | ||
Drug distribution | √ | ||
Drug recovery | √ | √ | |
Compliance judgement | √ | √ | |
Evaluation index | |||
WHOQOL-BREF | √ | √ | √ |
NIHSS | √ | √ | √ |
Safety observation | |||
Vital signs | √ | √ | √ |
AEs | √ | √ |
AEs, adverse events; ICF, informed consent form; NIHSS, National Institutes of Health Stroke Scale