Table 3 Safety Outcomes in the Safety Population

From: Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial

Outcome

ED Group (n = 97)a

Control Group (n = 103)a

Treatment Effect Metric

Unadjusted

Adjustedb

Treatment Difference (95% CI)

P Value

Treatment Difference (95% CI)

P Value

sICH at 48 h, No. (%)c

5/94 (5.3)

11/101 (10.9)

OR

0.46 (0.15–1.37)

0.17

0.39 (0.11 to 1.35)

0.14

Intracerebral hemorrhage at 48 h, No. (%)c

PH−1

3/94 (3.2)

11/101 (10.9)

OR

0.27 (0.07−1.00)

0.05

0.21 (0.05–0.89)

0.03

PH-2

5/94 (5.3)

4/101 (4.0)

OR

1.36 (0.36–5.23)

0.65

1.08 (0.25–4.73)

0.92

HI−1

3/94 (3.2)

1/101 (1.0)

OR

3.30 (0.34–32.26)

0.31

4.01 (0.21–76.58)

0.36

HI-2

4/94 (4.3)

13/101 (12.9)

OR

0.30 (0.09–0.96)

0.04

0.27 (0.08–0.95)

0.04

SAE within 90 days, No. (%)d

21 (21.6)

30 (29.1)

HRe

0.75 (0.43−1.30)

0.30

0.90 (0.50−1.60)

0.72

  1. sICH symptomatic intracranial hemorrhage, PH parenchymal hemorrhage, HI hemorrhagic infarct, SAE serious adverse events.
  2. aFive patients lacked safety outcomes due to discharging within 48 h after receiving the treatment (3 in ED group and 2 in Control group).
  3. bAdjusted for key prognostic covariates (age, sex, pre-stroke score on the modified Rankin Scale, NIHSS score at baseline, previous ischemic stroke, time from onset to recanalization, cerebral collateral circulation grade, number of thrombectomy device passes, and intravenous thrombolysis).
  4. cDefined according to European Cooperative Acute Stroke Study (ECASS).
  5. dSAE included parenchymal hemorrhage, subarachnoid hemorrhage, cerebral hernia, respiratory failure, acute ischemic stroke, cerebral edema, sudden cardiac death, gastrointestinal hemorrhage, liver dysfunction, etc. Two patients occurred SAE presented with liver dysfunction possibly related to ED.
  6. eCalculated with Cox regression model.
Back to article page