Placebo event rate (%) | NAC event rate* (%) | Event rate reduction (%) | Power** (%) |
---|
24 | 6.0 | 75 | 97.5 |
30 | 7.5 | 75 | 99.3 |
36 | 9.0 | 75 | 99.8 |
24 | 8.0 | 66.7 | 90.1 |
30 | 10.0 | 66.7 | 96.0 |
36 | 12.0 | 66.7 | 98.7 |
24 | 12.0 | 50 | 62.3 |
30 | 15.0 | 50 | 73.1 |
36 | 18.0 | 50 | 80.6 |
- *12-month event rates for the 35% of patients not taking concomitant IPF medication. The remaining 65% are assumed to have half the shown event rate in each arm based on taking IPF concomitant medication
- **Power estimates assume censorship/dropout rate of 10% for the NAC vs placebo comparison in 200 randomized participants. Calculations assume a 2-sided Type-I error rate of 0.05. Follow-up is planned to be 24Â months for all patients. Power calculations were based on a log-rank test with assumed event rates following an exponential distribution