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Table 3 Subgroup analyses of the individual trials and combined data set (one-stage IPDMM)

From: Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical analysis plan for the trials and for the individual patient data meta-analysis

  

FOCUS

AFFINITY

EFFECTS

Combined

  

Fluoxetine

(n=)

Placebo

(n=)

COR

(95% CI)

p-value

Fluoxetine

(n=)

Placebo

(n=)

COR

(95% CI)

p-value

Fluoxetine

(n=)

Placebo

(n=)

COR

(95% CI)

p-value

Fluoxetine

(n=)

Placebo

(n=)

COR

(95% CI)

p-value

Probability of being alive and independent at 6 months using SSV

0 to ≤0∙15

            

0.15-1.00

            

Delay from onset to randomisation

2-8 days

            

9-15 days

            

Motor deficit

No

            

Yes

            

Aphasia

No

            

Yes

            

Stroke type

Haemorrhagic

            

Ischaemic

            

Age group

≤70 years old

            

>70 years old

            

Who gave consent

Proxy

            

Patient

            

Inability to assess mood

No

            

Yes

            

Baseline depression

No

            

Yes

            

Country

UK

            

Vietnam

            

New Zealand

            

Australia

            

Sweden

            

Ethnicity

Asian

            

Black

            

Chinese

            

White

            

Other

            

Trial

FOCUS

            

AFFINITY

            

EFFECTS

            
  1. Abbreviations: CI confidence interval, COR common odds ratio, SSV six simple variables