Table 2 Study schedule
Visit | Screening | Baseline | Visit 2* | Visit 3* | Visit 4* | Visit 5* | Visit 6* | Visit 7* | Visit 8* | Final visit/withdrawal | Follow-up call |
|---|---|---|---|---|---|---|---|---|---|---|---|
Week | Day -14 to -1 | 0 | 2 | 4 | 6 | 8 | 12 | 16 | 20 | 24 | 28 |
Informed consent |
| ||||||||||
In/exclusion criteria |
|
| |||||||||
Randomization |
| ||||||||||
Demographics |
| ||||||||||
Medical history |
|
| |||||||||
Physical examination |
|
| |||||||||
Vital signs |
|
|
|
|
|
|
|
|
|
| |
On site assessment of haemoglobin level |
|
|
|
|
|
|
|
| |||
Biochemistry and haematology |
|
|
|
|
|
|
|
|
|
| |
Assay for anti-erythropoietin antibodies |
|
|
|
| |||||||
Echocardiogram |
|
| |||||||||
Retinopathy testing1 |
|
| |||||||||
Serum pregnancy test |
|
| |||||||||
Urinalysis2 |
|
|
| ||||||||
Investigational product dispensed |
|
|
|
|
|
|
|
| |||
Adverse events |
|
|
|
|
|
|
|
|
|
|
|
Prior and concomitant medication |
|
|
|
|
|
|
|
|
|
| |
Drug compliance |
|
|
|
|
|
|
|
|
