Table 5.
Spirometry outcomes in the per-protocol population (n=189)
|
Day 56 (n=189) |
Day 180 (n=186) |
Day 540 (n=98) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unadjusted |
Adjusted |
Unadjusted |
Adjusted |
Unadjusted |
Adjusted |
|||||||
| Mean (95% CI) | p value | Mean (95% CI) | p value | Mean (95% CI) | p value | Mean (95% CI) | p value | Mean (95% CI) | p value | Mean (95% CI) | p value | |
| FEV1% | ||||||||||||
| CC-11050 | 3·54% (−5·57 to 12·66) | 0·44 | 1·63% (−5·23 to 8·49) | 0·64 | 8·40% (−0·24 to 17·04) | 0·057 | 6·30% (0·06 to 12·54) | 0·048 | 7·33% (−5·04 to 19·71) | 0·24 | 0·58% (−9·09 to 10·25) | 0·91 |
| Everolimus | 5·63% (−3·68 to 14·95) | 0·23 | 0·40% (−6·62 to 7·42) | 0·91 | 11·66% (2·84 to 20·49) | 0·010 | 6·56% (0·18 to 12·95) | 0·044 | 7·50% (−4·42 to 19·42) | 0·22 | 1·92% (−7·36 to 11·20) | 0·68 |
| Auranofin | −6·17% (−15·28 to 2·95) | 0·18 | −5·14% (−11·96 to 1·68) | 0·14 | −3·70% (−12·40 to 5·00) | 0·40 | −2·79% (−9·04 to 3·45) | 0·38 | −5·45% (−17·38 to 6·47) | 0·37 | −5·44% (−14·62 to 3·74) | 0·24 |
| Ergocalciferol | −0·64% (−9·76 to 8·48) | 0·89 | −2·82% (−9·65 to 4·00) | 0·42 | 2·35% (−6·34 to 11·05) | 0·59 | 0·61% (−5·64 to 6·86) | 0·85 | 5·03% (−7·03 to 17·10) | 0·41 | −0·52% (−9·91 to 8·87) | 0·91 |
| FVC, L | ||||||||||||
| CC-11050 | −0·04 (−0·41 to 0·32) | 0·82 | 0·07 (−0·18 to 0·32) | 0·59 | 0·07 (−0·30 to 0·43) | 0·71 | 0·18 (−0·09 to 0·45) | 0·18 | −0·16 (−0·69 to 0·38) | 0·56 | −0·09 (−0·52 to 0·34) | 0·67 |
| Everolimus | 0·11 (−0·26 to 0·48) | 0·57 | 0·11 (−0·14 to 0·36) | 0·39 | 0·09 (−0·28 to 0·47) | 0·62 | 0·11 (−0·17 to 0·38) | 0·44 | −0·35 (−0·87 to 0·16) | 0·18 | −0·12 (−0·54 to 0·29) | 0·56 |
| Auranofin | −0·14 (−0·50 to 0·23) | 0·45 | −0·04 (−0·28 to 0·21) | 0·77 | −0·12 (−0·49 to 0·25) | 0·52 | −0·02 (−0·29 to 0·25) | 0·89 | −0·27 (−0·79 to 0·25) | 0·30 | −0·11 (−0·53 to 0·31) | 0·61 |
| Ergocalciferol | −0·15 (−0·51 to 0·22) | 0·43 | −0·05 (−0·29 to 0·20) | 0·72 | −0·20 (−0·57 to 0·17) | 0·29 | −0·04 (−0·31 to 0·23) | 0·78 | −0·18 (−0·70 to 0·34) | 0·49 | −0·14 (−0·55 to 0·28) | 0·52 |
Mean values indicate differences from the control group, before and after adjustment for differences from controls at baseline by ANCOVA. FEV1 was adjusted for baseline differences in FEV1. FVC was adjusted for baseline differences in FVC. Findings at 540 days are limited by reduced statistical power, as only 98 patients could be recalled for additional follow-up under a protocol amendment. FEV1%=forced expiratory volume in 1 s as a proportion of predicted. FVC=forced vital capacity.