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. 2018 Nov 26;13(11):e0208142. doi: 10.1371/journal.pone.0208142

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