Assessments/Procedures (weeks) | Screen | W2 #1 | W4 #2 | W6 #3 | W8 #4 | W10 #5 | W12 #6 | W14 | W16 | W26 | W52 |
Written informed consent/HIPPA | X | ||||||||||
Inclusion/Exclusion criteria | X | ||||||||||
Baseline medical history and physical examination | X | ||||||||||
Physical examination | X | X | X | X | X | X | X | ||||
Interim history | X | X | X | X | X | X | X | X | |||
Toxicity assessment, adverse experiences, modified Rankin score | X | X | X | X | X | X | X | X | X | X | X |
NIH Stroke Scale, Neuro-QoL Questionnaire | X | X | X | X | |||||||
ECG | X | ||||||||||
Administer study drug | X | X | X | X | X | X | |||||
Laboratory evaluation (plasma angiogenic/inflammatory markers): VEGF, FGF2, CRP, ESR, IL-1, IL-2, IL-6, MPO, TNF-α | X | X | X | X | |||||||
Laboratory evaluations*: complete blood count with differential, creatinine, blood urea nitrogen, liver function tests, prothrombin time, partial thromboplastin time | X | X | X | X | X | X | X | X | X | ||
Laboratory evaluations*: urine protein/creatinine ratio (urine dipstick for protein prior to infusions) | X | X | X | X | |||||||
MRI | X | X | X | ||||||||
Pregnancy test (if applicable) | X | X | X |
*Completed within 3 days of bevacizumab infusion when applicable.
CRP, C reactive protein; ESR, erythrocyte sedimentation rate; FGF2, fibroblast growth factor 2; IL, interleukin; MPO, myeloperoxidase; Neuro-QoL, Quality of Life in Neurologic Disorders; NIH, National Institutes of Health; TNF-α, tumour necrosis factor α; VEGF, vascular endothelial growth factor.