Table 4.
Baseline and week 16 values and changes in exploratory efficacy parameters
| Pt ID | BL | Week 16 | Δ | BL | Week 16 | Δ | BL | Week 16 | Δ |
|---|---|---|---|---|---|---|---|---|---|
| 6-min Walk distance (m) |
Exercise treadmill test (metabolic equivalents) |
Right ventricular ejection fraction (3-dimensional) (%) |
|||||||
| 1 | 411 | 472 | 61 | 6.1 | 6.4 | 0.3 | 23 | 17 | −6 |
|
| |||||||||
| 2 | 585 | 541 | −44 | 6.3 | 7.8 | 1.5 | 28 | 38 | 10 |
|
| |||||||||
| 3 | 481 | 495 | 14 | 7.3 | 8.9 | 1.6 | 27 | 36 | 9 |
|
| |||||||||
| 4 | 492 | 421 | −71 | 4.6 | 6.4 | 1.8 | 33 | 46 | 13 |
|
| |||||||||
| 5 | 666 | 682 | 16 | 11.0 | 11.0 | 0.0 | 34 | 36 | 2 |
|
| |||||||||
| 6 | 398 | 445 | 47 | 6.1 | 6.8 | 0.7 | 22 | 31 | 9 |
|
| |||||||||
| 7 | 349 | 389 | 40 | 5.2 | 5.3 | 0.1 | 16 | 30 | 14 |
|
| |||||||||
| 8 | 265 | 288 | 23 | 4.1 | 4.4 | 0.3 | 41 | 43 | 2 |
|
| |||||||||
| 9a | 262 | 296 | 34 | 3.3 | 3.7 | 0.4 | 19 | 20 | 1 |
|
| |||||||||
| 10 | 363 | 448 | 85 | 6.3 | 8.9 | 2.6 | 18 | 16 | −2 |
|
| |||||||||
| 11 | 473 | 437 | −36 | 5.6 | 4.8 | −0.8 | 17 | 13 | −4 |
|
| |||||||||
| Median | 411 | 445 | 23 | 6.1 | 6.4 | 0.4 | 23 | 31 | 2 |
|
| |||||||||
| Min | 262 | 296 | −71 | 3.3 | 3.7 | −0.8 | 16 | 13 | −6 |
|
| |||||||||
| Max | 666 | 682 | 85 | 11.0 | 11.0 | 2.6 | 41 | 46 | 14 |
|
| |||||||||
| P value | 0.33 | 0.02 | 0.09 | ||||||
| Mean pulmonary arterial pressure (mm Hg) |
Cardiac output/cardiac index (l/min)/(l/min/m2) |
Pulmonary vascular resistance index (Units × m2) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | 53 | 61 | 8 | 3.4/1.9 | 2.8/1.6 | −0.6/−0.3 | 22 | 34 | 12 |
|
| |||||||||
| 2 | 63 | 59 | −4 | 4.6/2.4 | 4.3/2.3 | −0.3/−0.1 | 21 | 21 | 0.0 |
|
| |||||||||
| 3 | 55 | 47 | −8 | 4.8/2.4 | 4.6/2.3 | −0.2/−0.1 | 17 | 17 | 0.0 |
|
| |||||||||
| 4 | 48 | 40 | −8 | 7.1/4.2 | 6.4/3.8 | −0.7/−0.4 | 9 | 8 | −1.0 |
|
| |||||||||
| 5 | 36 | 35 | −1 | 7.6/3.6 | 7.0/3.4 | −0.6/−0.2 | 7 | 7 | 0.0 |
|
| |||||||||
| 6 | 45 | 43 | −2 | 4.6/3.1 | 3.2/2.2 | −1.4/−0.9 | 12 | 16 | 4 |
|
| |||||||||
| 7 | 51 | 36 | −15 | 6.5/3.5 | 5.5/2.9 | −1.0/−0.6 | 11 | 8 | −3.0 |
|
| |||||||||
| 8 | 41 | 35 | −6 | 9.3/5.0 | 6.5/3.5 | −2.8/−1.5 | 5 | 9 | 4 |
|
| |||||||||
| 9a | 48 | 53 | 5 | 3.7/2.3 | 3.6/2.2 | −0.1/−0.1 | 20 | 18a | −2.0 |
|
| |||||||||
| 10 | 58 | 55 | −3 | 2.6/1.9 | 2.4/1.7 | −0.2/−0.2 | 25 | 24 | −1.0 |
|
| |||||||||
| 11 | 64 | 64 | 0 | 2.7/1.7 | 2.2/1.5 | −0.5/−0.2 | 31 | 35 | 4.0 |
|
| |||||||||
| Median | 51 | 47 | −3 | 4.6/2.4 | 4.3/2.3 | −0.6/−0.2 | 17 | 17 | 0.0 |
|
| |||||||||
| Min | 36 | 35 | −15 | 2.6/1.7 | 2.2/1.5 | −2.8/−1.5 | 5 | 7 | 0.0 |
|
| |||||||||
| Max | 64 | 64 | 8 | 9.3/5.0 | 7.0/3.8 | 0.1/−0.1 | 31 | 35 | 12 |
|
| |||||||||
| P value | 0.11 | <0.01b | 0.62 | ||||||
Δ, change; BL, baseline.
Tests delayed 4 weeks because of severe respiratory infection.
Applies to both cardiac output and cardiac index.