Table 2.
AETHER Schedule of Assessments
| Visit | Screening ± 28 d | Baseline 2-4 wk | Day 1 Week 1 | Day 2 | Week 1 (Day 7) | Week 2 (Day 14) | Month 1 (Week 4) | Month 3 Week 12 (±3-5 d) | Month 6 Week 24 (±3-5 d) | Month 9 Week 36 (±3-5 d) | Month 12 Week 48 (±3-5 d) | Month 15 Week 60 (±3-5 d) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Informed consent | x | |||||||||||
| Full medical history | x | |||||||||||
| Physical examination | x | x | x | x | x | x | x | x | x | x | x | x |
| Chem7, LFTs, PT/INR | x | x | x | x | x | x | x | |||||
| Urinalysis, CBC, and metabolic profile | x | x | x | x | x | x | x | x | ||||
| Spirometry | x | x | x | x | x | x | ||||||
| Dlco | x | x | x | x | x | x | ||||||
| Echocardiogram | x | x | ||||||||||
| ECG | x | x | x | x | x | x | x | x | x | x | x | x |
| Treatment | x | |||||||||||
| Review adverse events | x | x | x | x | x | x | x | x | x | |||
| HRCT | x | x | x | |||||||||
| 6-MWT | x | x | x | x | x | x | ||||||
| Lung volumes | x | x | x | x | x | x | ||||||
| QOL questionnaires | x | x | x | x | x | x | x |
CBC = complete blood count; Chem7 = sodium, potassium, chloride, uric acid, glucose, blood urea nitrogen, creatinine; Dlco = diffusing capacity of the lungs for carbon monoxide; HRCT = high-resolution CT; LFTs = liver function tests (alanine transaminase, alkaline phosphatase, aspartate transaminase, bilirubin, albumin, total protein, gamma glutamyl transpeptidase); PT/INR = prothrombin time (PT) along with its derived measures of prothrombin ratio and international normalized ratio (INR); QOL = quality of life. See Table 1 legend for expansion of other abbreviations.