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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