Table 1.
Study design and schema.
| Assessment | Fluid status | Pregnancy test (Urine) | Safety tests (Na, K) | Coagulation tests (VWF, VIII, mRNA) | Heme tests (H/H, platelets) | Diary | |||
|---|---|---|---|---|---|---|---|---|---|
| Ht | Wt | Exam | Swelling | ||||||
| PRE-TRIAL | X | X | X | X | X | X | - | ||
| In-hospital assessment | X | X | |||||||
| Day 1–4 | |||||||||
| DURING TRIAL | – | – | – | X | X | - | - | - | X |
| Home assessment | |||||||||
| Month 1–6 | |||||||||
| POST-TRIAL | X | X | X | X | - | X | X | X | X |
| Outpatient assessment | |||||||||
| Day 10 after rhIL-11 | |||||||||
Fluid status, including height, weight, physical exam for congestive heart failure and papilledema, and assessment for finger or ankle swelling, were performed in hospital, and the latter also at home. Urine pregnancy tests were performed daily in-hospital and monthly at home before taking rhIL-11. Safety tests, including Na+ and K+, were performed in-hospital. Coagulation tests, including VWF assays, VIII assays, closure times, and VWF mRNA, were performed in-hospital. Heme tests, including haemoglobin, haematocrit (H/H) and platelets, were performed in-hospital. All assessments were repeated day 10 post rhIL-11, month 6, in clinic. Diaries, including all symptoms, concomitant medications, time and date of orange juice daily before rhIL-11, and time and date of rhIL-11 injections, were maintained during study by subjects and reviewed with nurses at monthly outpatient visits, at which time all used supplies were returned and new supplies were provided.