Summary of clinical and laboratory evaluations
| Baseline (before treatment initiation) . | During treatment Arm A . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | Initial response evaluation (Arm A and B) . | Between initial and final evaluation (Arm A and B) . | Final response evaluation (Arm A and B) . | Follow-up . | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Days | 0 | 7-35 | 4 | 14 | 18 | 28 | 32 | 42-46 | 180∗ | ||
| Eligibility (inclusion/exclusion) criteria | † | ||||||||||
| Demographics | † | ||||||||||
| General medical history/present medical conditions | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| Physical examination/vital signs | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| Complete blood cell count | † | Weekly | † | † | † | † | † | † | Every 15 of 21 d | † | †,‡ |
| Serum biochemistry (glucose, urea, creatinine, uric acid, albumin, total protein and electrophoresis, bilirubin, alkaline phosphatase, AST, ALT, LDH, sodium, potassium, and calcium) | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| BM and PB cytomorphology | † | †,§ | |||||||||
| Autoimmunity markers | † | ||||||||||
| Coagulation: PT, aPTT, fibrinogen, D-dimer, and AT | † | ||||||||||
| Cardiac evaluation: visit. If necessary: electrocardiogram and echocardiogram | † | ||||||||||
| Chest radiograph | † | ||||||||||
| Abdomen ultrasound | † | ||||||||||
| Evaluation of bleeding symptoms (indication of the score) | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| Baseline (before treatment initiation) . | During treatment Arm A . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | During treatment Arm B . | Initial response evaluation (Arm A and B) . | Between initial and final evaluation (Arm A and B) . | Final response evaluation (Arm A and B) . | Follow-up . | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Days | 0 | 7-35 | 4 | 14 | 18 | 28 | 32 | 42-46 | 180∗ | ||
| Eligibility (inclusion/exclusion) criteria | † | ||||||||||
| Demographics | † | ||||||||||
| General medical history/present medical conditions | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| Physical examination/vital signs | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| Complete blood cell count | † | Weekly | † | † | † | † | † | † | Every 15 of 21 d | † | †,‡ |
| Serum biochemistry (glucose, urea, creatinine, uric acid, albumin, total protein and electrophoresis, bilirubin, alkaline phosphatase, AST, ALT, LDH, sodium, potassium, and calcium) | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
| BM and PB cytomorphology | † | †,§ | |||||||||
| Autoimmunity markers | † | ||||||||||
| Coagulation: PT, aPTT, fibrinogen, D-dimer, and AT | † | ||||||||||
| Cardiac evaluation: visit. If necessary: electrocardiogram and echocardiogram | † | ||||||||||
| Chest radiograph | † | ||||||||||
| Abdomen ultrasound | † | ||||||||||
| Evaluation of bleeding symptoms (indication of the score) | † | Weekly | † | † | † | † | † | † | † | † | †,‡ |
ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; AT, antithrombin; BM, bone marrow; LDH, lactate dehydrogenase; PB, peripheral blood; PT, prothrombin time; PTT, activated partial thromboplastin time.
From initial response evaluation.
Time when an evaluation should be made.
Every month until 12th month; thereafter, almost every 2 months until 24th month, and every 3 months until 36th month.
In patients aged >60 years who were unresponsive to treatment or who had lost the response, bone marrow aspirate, bone marrow biopsy, and evaluation of karyotype are indicated.