Table 1

Schedule of clinical events

Assessments/Procedures
(weeks)
ScreenW2
#1
W4
#2
W6
#3
W8
#4
W10
#5
W12
#6
W14W16W26W52
Written informed consent/HIPPAX
Inclusion/Exclusion criteriaX
Baseline medical history and physical examinationX
Physical examinationXXXXXXX
Interim historyXXXXXXXX
Toxicity assessment, adverse experiences, modified Rankin scoreXXXXXXXXXXX
NIH Stroke Scale, Neuro-QoL QuestionnaireXXXX
ECGX
Administer study drugXXXXXX
Laboratory evaluation (plasma angiogenic/inflammatory markers): VEGF, FGF2, CRP, ESR, IL-1, IL-2, IL-6, MPO, TNF-αXXXX
Laboratory evaluations*: complete blood count with differential, creatinine, blood urea nitrogen, liver function tests, prothrombin time, partial thromboplastin timeXXXXXXXXX
Laboratory evaluations*: urine protein/creatinine ratio (urine dipstick for protein prior to infusions)XXXX
MRIXXX
Pregnancy test (if applicable)XXX
  • *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.