Table 4. Number of patients with serious adverse events during follow-up at day 90 classified by local investigators and central adjudicators: GTN vs no GTN and continue vs stop.
GTN (n = 2000) | No GTN (n = 2011) | p-value* | Continue (n = 1053) | Stop (n = 1044) | p-value* | |
---|---|---|---|---|---|---|
Any SAE | ||||||
Local Investigator | 522 | 509 | 0.57 | 312 | 297 | 0.55 |
Central Adjudicator | 520 | 502 | 0.45 | 310 | 294 | 0.52 |
Complication of initial stroke | ||||||
Local Investigator | 67 | 53 | 0.18 | 26 | 36 | 0.19 |
Central Adjudicator | 40 | 31 | 0.27 | 19 | 16 | 0.63 |
Extension of initial stroke | ||||||
Local Investigator | 50 | 37 | 0.15 | 32 | 23 | 0.23 |
Central Adjudicator | 59 | 37 | 0.021 | 33 | 23 | 0.19 |
Symptomatic intracranial haemorrhage | ||||||
Local Investigator | 23 | 19 | 0.52 | 10 | 18 | 0.12 |
Central Adjudicator | 27 | 17 | 0.13 | 11 | 16 | 0.32 |
Recurrent stroke | ||||||
Local Investigator | 57 | 32 | 0.007 | 29 | 27 | 0.81 |
Central Adjudicator | 47 | 35 | 0.17 | 25 | 27 | 0.80 |
Myocardial infarction | ||||||
Local Investigator | 18 | 25 | 0.29 | 9 | 18 | 0.077 |
Central Adjudicator | 19 | 22 | 0.65 | 11 | 16 | 0.32 |
Sudden cardiac death | ||||||
Local Investigator | 3 | 5 | 0.48 | 1 | 3 | 0.31 |
Central Adjudicator | 6 | 6 | 0.99 | 1 | 5 | 0.10 |
Other cardiovascular event | ||||||
Local Investigator | 119 | 103 | 0.25 | 64 | 72 | 0.45 |
Central Adjudicator | 109 | 97 | 0.37 | 60 | 66 | 0.55 |
Pulmonary embolism | ||||||
Local Investigator | 26 | 17 | 0.16 | 10 | 11 | 0.81 |
Central Adjudicator | 26 | 19 | 0.29 | 11 | 13 | 0.70 |
Pneumonia | ||||||
Local Investigator | 89 | 100 | 0.44 | 74 | 50 | 0.030 |
Central Adjudicator | 117 | 122 | 0.77 | 88 | 63 | 0.040 |
Other event | ||||||
Local Investigator | 210 | 220 | 0.65 | 140 | 115 | 0.11 |
Central Adjudicator | 212 | 212 | 0.95 | 134 | 119 | 0.35 |
*p-values are from a chi-squared test between treatment groups
GTN = Glyceryl trinitrate