Skip to main content

Table 1 Baseline data collected before randomisation in the three trials

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 (N= 3127) AFFINITY (N=1280) EFFECTS (N=1500) Combined (N=5907)
   Fluoxetine
(n=1564)
Placebo
(n= )
All
(n= )
Fluoxetine
(n= )
Placebo
(n= )
All
(n= )
Fluoxetine
(n= )
Placebo
(n= )
All
(n= )
Fluoxetine
(n= )
Placebo
(n= )
All
(n= )
Sex Women N(%)            
Men N(%)            
Age Age ≤70 years N(%)            
Age >70 years N(%)            
Mean (sd) Mean (sd)            
Ethnicity Asian N(%)            
Black N(%)            
Chinese N(%)            
White N(%)            
Other N(%)            
Marital Status Married N(%)            
Partner N(%)            
Divorcer/separated N(%)            
Widowed N(%)            
Single N(%)            
Other N(%)            
Living arrangement Living with someone N(%)            
Living alone N(%)            
Living in an inst. N(%)            
Other N(%)            
Employment FT N(%)            
PT N(%)            
Retired N(%)            
Unemployed/disabled N(%)            
Other N(%)            
Independent before stroke N(%)            
Previous medical history Coronary heart disease N(%)            
Ischaemic stroke/TIA N(%)            
Diabetes N(%)            
Hyponatraemia N(%)            
Intracranial bleed N(%)            
Upper GI bleed N(%)            
Bone fractures N(%)            
Depression N(%)            
Stroke diagnosis Not-stroke N(%)            
Ischaemic stroke N(%)            
Intracerebral haemorrhage N(%)            
OCSP classification of Ischaemic stroke Total anterior circulation infarct N(%)            
Partial anterior circulation infarct N(%)            
Lacunar infarct N(%)            
Posterior circulation infarct N(%)            
Uncertain N(%)            
Cause of stroke, modified TOAST classification Large artery disease N(%)            
Small vessel disease N(%)            
Embolism from heart N(%)            
Another cause N(%)            
Unknown/uncertain N(%)            
Predictive variables Able to walk at time of randomisation N(%)            
Able to lift both arms off bed N(%)            
Able to talk and not confused N(%)            
Predicted 6-month outcome based on SSV Prob. of being alive and independent Q2(Q1,q3)            
0.00 to ≤ 0.15 N(%)            
>0.15 to 1.00 N(%)            
Neurological deficits NIHSS Q2(Q1,q3)            
Presence of motor deficit N(%)            
Presence of aphasia N(%)            
Depression at baseline Current diagnosis of depression N(%)            
Taking a non-SSRI antidepressant N(%)            
Current mood (PHQ-2) 2 yes responses N(%)            
1 yes response N(%)            
0 yes responses N(%)            
Delay (days) since stroke onset at randomisation Mean (sd) Mean (sd)            
2-8 days N(%)            
9-15 days N(%)            
Details of enrolment Enrolled as a hospital inpatient N(%)            
  Patient consented N(%)            
  Proxy consented N(%)            
  1. Abbreviations: FT full time, GI gastrointestinal, NIHSS National Institutes of Health stroke scale, OCSP Oxfordshire Community Stroke Project, PHQ-2 Patient Health Questionnaire 2-item, PT part time, sd standard deviation, SSRI selective serotonin reuptake inhibitor, SSV six simple variables, TIA transient ischaemic attack, TOAST Trial of ORG 10172 in Acute Stroke Treatment