Table 2.
Characteristics of primary endpoints in clinical trials with severe patients
| Continuous (N=16) | Binary (N=65) | Ordinal (N=24) | Time-to-event (N=44) | Other (N=4) | |
|---|---|---|---|---|---|
| Time frame | |||||
| ≤14 days | 3 (18.8%) | 12 (18.5%) | 6 (25.0%) | 3 (6.8%) | 1 (25.0%) |
| 15–30 days | 10 (62.5%) | 45 (69.2%) | 18 (75.0%) | 37 (84.1%) | 2 (50.0%) |
| >30 days | 3 (18.8%) | 8 (12.3%) | 0 (0.0%) | 4 (9.1%) | 1 (25.0%) |
| Evaluation of clinical course | |||||
| Improvement | - | 19 (29.2%) | - | 34 (77.3%) | - |
| Worsening | - | 39 (60.0%) | - | 6 (13.6%) | - |
| Unknown | - | 7 (10.8%) | - | 4 (9.1%) | - |
| Sample size (trials with 1 arma) | |||||
| (N=5) | (N=10) | (N=4) | (N=15) | (N=1) | |
| Mean (SD) | 101.2 (56.4) | 472.3 (407.3) | 279.3 (226.1) | 335.7 (274.5) | 180 ( - ) |
| Median (IQR) | 76 (76, 76) | 239 (197.8, 565.5) | 223.5 (173.5, 329.3) | 200 (140, 600) | 180 ( - ) |
| Sample size (trials with 2 armsa) | |||||
| (N=6) | (N=35) | (N=15) | (N=22) | (N=1) | |
| Mean (SD) | 420.7 (175.0) | 577.0 (808.8) | 476.3 (606.1) | 498.4 (320.8) | 600 ( - ) |
| Median (IQR) | 468 (341.5, 500) | 376 (265, 530) | 330 (100, 425) | 409 (259.5, 677.5) | 600 ( - ) |
| Sample size (trials with ≥3 armsa) | |||||
| (N=5) | (N=20) | (N=5) | (N=7) | (N=2) | |
| Mean (SD) | 457.8 (498.2) | 1124.0 (864.4) | 850.0 (1271.8) | 1199.1 (733.5) | 109.5 (48.8) |
| Median (IQR) | 189 (50, 1000) | 1200 (283.5, 1770.5) | 450 (100, 500) | 1034 (750, 159) | 109.5 (-) |
aA single drug with multiple doses that was placed under the same “Arm” in Interventions was considered as one arm
SD standard deviation, IQR interquartile range