Table 2.
Primary and secondary endpoint results after 4 weeks of follow-up in the FAS, n (%)
| Items | Wenxin Keli group (n = 600) | Placebo group (n = 600) | Rate difference, % (95% CI) | P |
|---|---|---|---|---|
| Primary endpoints | ||||
| SER | 251 (41.8) | 94 (15.7) | ||
| ER | 252 (42.0) | 167 (27.8) | ||
| TER | 503 (83.8) | 261 (43.5) | 37.4 (30.0–45.5) | <0.001 |
| Secondary endpoints | ||||
| Palpitation | ||||
| SER | 133 (22.2) | 46 (7.7) | ||
| ER | 327 (54.5) | 180 (30.0) | ||
| TER | 460 (76.7) | 226 (37.7) | 25.1 (18.8–32.2) | <0.001 |
| Chest discomfort | ||||
| SER | 108 (18.0) | 54 (9.0) | ||
| ER | 322 (53.6) | 157 (26.1) | ||
| TER | 430 (71.6) | 211 (35.1) | 27.3 (20.4–35.0) | <0.001 |
| Insomnia | ||||
| SER | 81 (13.5) | 28 (4.7) | ||
| ER | 281 (46.9) | 125 (20.9) | ||
| TER | 362 (60.4) | 153 (25.6) | 27.0 (19.7–35.6) | <0.001 |
| Fatigue | ||||
| SER | 80 (13.3) | 30 (5.0) | ||
| ER | 297 (49.5) | 151 (25.2) | ||
| TER | 377 (62.8) | 181 (30.2) | 27.3 (19.7–36.0) | <0.001 |
FAS: Full analysis set; CI: Confidence interval; SER: Significantly effective response; ER: Effective response; TER: Total effective response; Rate difference: Rate of TER in Wenxin Keli group - Rate of TER in placebo group; P: Wenxin Keli group vs. Placebo group.