| 1 Progression to threshold ROP by 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.70, 1.02] |
| 1.1 Infants with severe ROP at randomisation (stratum A) |
1 |
180 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.60, 1.13] |
| 1.2 Infants with less severe ROP at randomisation (stratum B) |
1 |
469 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.68, 1.07] |
| 2 Blindness or severe visual impairment at 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.52, 2.26] |
| 3 Macular ectopia at 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.47, 2.13] |
| 4 Mortality between randomization and 3 months corrected age |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 4.1 Pulmonary deaths |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.67 [0.40, 6.94] |
| 4.2 Non pulmonary deaths |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.25, 3.98] |
| 4.3 All deaths |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.29 [0.49, 3.42] |
| 5 Remained in hospital at 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.86 [1.12, 3.10] |
| 6 Remained on supplemental oxygen at 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.26 [1.05, 1.51] |
| 7 Pulmonary morbidities at or by 3 months corrected age |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 7.1 Pneumonia / CLD events |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.52 [0.94, 2.47] |
| 7.2 Rehospitalization for pulmonary reasons |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.60, 1.32] |
| 7.3 Apnea/bradys triple baseline rate |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.16 [0.70, 1.91] |
| 7.4 Methylxanthines |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.75, 1.60] |
| 7.5 Postnatal steroids |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.76, 1.67] |
| 7.6 Diuretics |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.47 [1.16, 1.87] |
| 7.7 Any adverse pulmonary event by 3 months corrected age |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.24 [1.06, 1.44] |
| 8 Growth / weight gain |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 8.1 Weight gain in first two weeks post randomisation (grams) |
1 |
649 |
Mean Difference (IV, Fixed, 95% CI) |
‐13.0 [‐34.55, 8.55] |
| 8.2 Weight gain from randomisation to 3 months corrected age (grams) |
1 |
649 |
Mean Difference (IV, Fixed, 95% CI) |
‐80.0 [‐237.77, 77.77] |
| 9 Sensitivity analysis for progression to threshold ROP |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 9.1 Worst case |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.86, 1.21] |
| 9.2 Best case |
1 |
649 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.72 [0.60, 0.85] |
| 9.3 All who completed primary eye endpoint assessment |
1 |
597 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.71, 1.01] |
