Relationship between outcome and headache by day 7, in participants who received GTN
| Headache | Total | Yes | No | Unadjusted OR/HR/MD (95% CI) | 2p | Adjusted OR/HR/MD (95% CI) | P value |
| Day 7 (%)* | |||||||
| Death | 1996 | 2 (0.6) | 59 (3.6) | 0.15 (0.04 to 0.61) | 0.008 | 0.24 (0.06 to 1.00) | 0.050 |
| Deterioration/death | 1992 | 14 (3.9) | 166 (10.2) | 0.36 (0.21 to 0.62) | <0.001 | 0.45 (0.25 to 0.82) | 0.009 |
| Recurrence | 1995 | 3 (0.8) | 39 (2.4) | 0.34 (0.11 to 1.12) | 0.076 | 0.41 (0.12 to 1.36) | 0.15 |
| sICH | 1996 | 4 (1.1) | 18 (1.1) | 1.01 (0.34 to 3.00) | 0.99 | 1.15 (0.36 to 3.69) | 0.82 |
| Hypotension | 1996 | 6 (1.7) | 50 (3.1) | 0.54 (0.23 to 1.26) | 0.16 | 0.52 (0.22 to 1.24) | 0.14 |
| Hypertension | 1996 | 40 (11.1) | 99 (6.1) | 1.94 (1.32 to 2.86) | 0.001 | 1.81 (1.19 to 2.76) | 0.006 |
| SSS (/58) | 1992 | 43.4 (13) | 38.2 (16.3) | 5.25 (3.45 to 7.05) | <0.001 | 0.88 (−0.25 to 2.01) | 0.13 |
| SAEs by day 7 (%)* | |||||||
| Cerebral oedema | 1996 | 4 (1.1) | 11 (0.7) | 1.66 (0.53 to 5.24) | 0.39 | 2.90 (0.77 to 10.85) | 0.12 |
| Complication | 1996 | 0 (0) | 22 (1.3) | – | – | – | – |
| Extension | 1996 | 5 (1.4) | 48 (2.9) | 0.47 (0.18 to 1.18) | 0.11 | 0.53 (0.21 to 1.38) | 0.19 |
| Hospital events | |||||||
| Length of stay (days)† | 1988 | 17.8 (20.7) | 21.4 (23.9) | −3.6 (−6.0 to −1.1) | 0.009 | 0.4 (−2.1 to 2.9) | 0.76 |
| Death (%)‡ | 1996 | 10 (2.8) | 149 (9.1) | 0.29 (0.15 to 0.55) | <0.001 | 0.44 (0.22 to 0.88) | 0.020 |
| Day 90 | |||||||
| Death (%)‡ | 1991 | 21 (5.8) | 210 (12.9) | 0.42 (0.27 to 0.67) | <0.001 | 0.64 (0.40 to 1.02) | 0.062 |
| mRS (/6)§ | 1996 | 2.6 (1.6) | 3.2 (1.7) | 0.58 (0.47 to 0.70) | <0.001 | 0.90 (0.73 to 1.10) | 0.30 |
| Barthel Index (/100)† | 1980 | 77 (31.4) | 63 (39.0) | 14.0 (10.2 to 17.7) | <0.001 | 3.7 (0.3 to 7.1) | 0.034 |
| MMSE (/30)† | 1003 | 13.8 (6) | 10.6 (7.6) | 3.2 (2.2 to 4.2) | <0.001 | 1.5 (0.6 to 2.4) | 0.002 |
| TICS-M (/30)† | 993 | 18.5 (8.8) | 14 (10.6) | 4.5 (3.1 to 5.9) | <0.001 | 2.0 (0.7 to 3.3) | 0.003 |
| Category fluency† | 1172 | 11.6 (7.5) | 8.7 (97.7) | 2.9 (1.8 to 4.0) | <0.001 | 1.3 (0.3 to 2.2) | 0.008 |
| ZDS (/102.5)† | 1630 | 54.6 (20.5) | 59.1 (24.3) | −4.5 (−7.4 to -1.6) | 0.002 | −0.9 (−3.5 to 1.7) | 0.48 |
| EQ-5D/HUS (/1)† | 1975 | 0.52 (0.39) | 0.45 (0.4) | 0.08 (0.03 to 0.12) | 0.001 | −0.01 (0.03 to 0.95) | 0.69 |
| EQ-VAS (/100)† | 1717 | 60.9 (28.0) | 55.5 (31.3) | 1.9 (1.6 to 9.1) | 0.005 | −0.5 (−3.8 to 2.8) | 0.76 |
Adjusted results are shown, with adjustment for age, sex, premorbid mRS score, previous stroke, diabetes mellitus, current nitrate use, time from onset to randomisation systolic blood pressure, total anterior circulation syndrome, Scandinavian Stroke Scale Score, stroke type, thrombolytic treatment, feeding status and continuation of prestroke antihypertensive drugs.
Data are number (%) or mean (SD), and OR, HR or mean difference (95% CIs).
*Comparisons by binary logistic regression.
†Multiple linear regression.
‡Cox regression.
§Ordinal logistic regression.
EQ-5D, European Quality of Life-5 dimensions; EQ-VAS, European Quality of Life-Visual Analogue Scale; HUS, health utility status; ICH, symptomatic intracranial haemorrhage; MD, mean difference; mRS, modified Rankin Scale; SAE, serious adverse event; SSS, Scandinavian Stroke Scale; TICS, Modified Telephone Interview for Cognitive Status; tMMSE, telephone Mini-Mental State Examination; ZDS, Zung Depression Scale.