Table 2 Primary and main secondary outcomes at days 4 and 90 in participants diagnosed with a stroke mimic. Data are number (%), median [IQR], or mean (standard deviation)
| Â | N | GTN | Sham | aOR/aMD (95% CI), adjusted | p-value |
|---|---|---|---|---|---|
Day 90 mRS (/6) | |||||
 All | 274 | 3 [1,4] | 3 [1,4] | 0.5 (0.3, 0.9) | 0.008 |
Sensitivity analyses | |||||
 Per-protocol | 245 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.026 |
 With multiple imputation | 297 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.013 |
 mean mRS | 274 | 2.5 (1.7) | 2.8 (1.9) | −0.5 (− 0.8, − 0.1) | 0.012 |
 mRS, unadjusted | 274 | 3 [1,4] | 3 [1,4] | 0.8 (0.5, 1.2) | 0.27 |
 mRS > 2 (%) | 274 | 72 (58.1) | 91 (60.7) | 0.6 (0.3, 1.2) | 0.18 |
 mRS > 2, unadjusted (%) | 274 | 72 (58.1) | 91 (60.7) | 0.9 (0.6, 1.5) | 0.66 |
 mRS, Received thrombolysis | 8 | 1 [1,2] | 1 [0,1] | – | – |
 mRS, No thrombolysis | 266 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.013 |
Admission | |||||
 NIHSS (/42) | 176 | 5.7 (6.2) | 5.3 (5.3) | −0.2 (−1.8, 1.4) | 0.82 |
 FAST (hospital admission) [/3] | 186 | 1.4 (1.1) | 1.5 (1.0) | −0.2 (− 0.5, 0.1) | 0.19 |
 OCSP, TACS (%) | 224 | 15 (15.8) | 25 (19.4) | 0.8 (0.4, 1.7) | 0.57 |
 GCS admission | 241 | 14.4 (1.4) | 14.2 (1.8) | 0.3 (−0.1, 0.7) | 0.13 |
Day 4 (or discharge) | |||||
 Death (%) | 279 | 2 (1.6) | 1 (0.6) | 2.2 (0.2, 29.8) | 0.56 |
 Patients with an SAE (%) | 279 | 6 (4.8) | 10 (6.5) | 0.8 (0.3, 2.5) | 0.73 |
 Infection (%) | 275 | 11 (8.9) | 17 (11.3) | 0.5 (0.2, 1.2) | 0.13 |
 Neurological deterioration (%) | 52 | 2 (7.7) | 3 (11.5) | 0.1 (0.0, 10.4) | 0.27 |
 Neurological deterioration, clinical (%) | 275 | 6 (4.8) | 4 (2.6) | 2.3 (0.6, 9.4) | 0.25 |
 Headache (%) | 274 | 8 (6.5) | 8 (5.3) | 1.4 (0.5, 4.1) | 0.54 |
 Hypotension, SBP < 90 mmHg (%) | 274 | 3 (2.4) | 0 (0) | – | – |
 Hypertension, SBP > 180 mmHg (%) | 274 | 17 (13.8) | 15 (9.9) | 2.1 (0.9, 4.9) | 0.090 |
 Feeding: non-oral (%) | 243 | 7 (6.4) | 7 (5.3) | 1.1 (0.4, 3.5) | 0.87 |
 Glasgow coma scale (/15) | 114 | 14.2 (2.5) | 14.2 (2.7) | 0.1 (−0.9, 1.1) | 0.79 |
 NIHSS (/43) | 57 | 4.5 (10.9) | 4.9 (9.7) | −0.6 (−6.4, 5.3) | 0.85 |
Hospital events | |||||
 Length of stay (days) | 279 | 4.8 (8.5) | 5 (6.9) | −0.6 (−2.4, 1.1) | 0.48 |
 Died in hospital (%) | 279 | 6 (4.8) | 3 (1.9) | 3.7 (0.8, 17.1) | 0.098 |
 Died or discharged to institution (%) | 271 | 13 (10.8) | 19 (12.6) | 0.8 (0.3, 1.7) | 0.49 |
Day 90 | |||||
 Death (%) | 281 | 8 (6.3) | 19 (12.3) | 0.5 (0.2, 1.2) | 0.11 |
 Disposition (%) | 260 | 1 [1,1] | 1 [1,1] | 0.6 (0.3, 1.2) | 0.14 |
 EQ-5D HUS (/1) | 257 | 0.5 (0.4) | 0.5 (0.4) | 0.1 (0.0, 0.2) | 0.031 |
 Quality of life, EQ-VAS (/100) | 240 | 57.3 (25.8) | 51.9 (30.3) | 6.5 (−0.2, 13.3) | 0.057 |
 Barthel Index (/100) | 253 | 75.2 (35.1) | 71.7 (39.2) | 6.3 (−1.4, 14.0) | 0.11 |
 Disability, Barthel index < 60 (%) | 253 | 27 (23.9) | 33 (23.6) | 0.9 (0.4, 1.9) | 0.73 |
 TICS-M | 112 | 19.3 (10.5) | 15 (11.0) | 3.3 (−0.0, 6.5) | 0.052 |
 tMMSE | 116 | 15.5 (8.0) | 12.7 (9.0) | 2.4 (−0.1, 4.9) | 0.061 |
 Animal naming | 114 | 14.7 (9.5) | 11.8 (10.1) | 1.7 (−1.3, 4.7) | 0.26 |
 Zung Depression Scale (/100) | 139 | 62.5 (24.3) | 62.4 (27.1) | −2.3 (−9.9, 5.3) | 0.55 |
 Home time (days) | 221 | 91 (36.2) | 85.7 (39.7) | 6.3 (−3.0, 15.7) | 0.19 |
 Global analysis | 112 | – | – | −0.1 (−0.2, 0.0) | 0.15 |