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Table 2 Outcome variables including adverse events and coding at 6 months (same table for 12 months without the AE section once the 12-month data becomes available from all trials but this will be a separate paper)

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= )

AFFINITY (N= )

EFFECTS (N= )

Combined (N= )

  

Fluoxetine

(n=)

Placebo

(n=)

All

(n=)

Fluoxetine

(n= )

Placebo

(n= )

All

(n= )

Fluoxetine

(n= )

Placebo

(n= )

All

(n= )

Fluoxetine

(n= )

Placebo

(n= )

All

(n= )

Modified Rankin Score

0 - No Symptoms

N(%)

           

1

N(%)

           

2

N(%)

           

3

N(%)

           

4

N(%)

           

5

N(%)

           

6 – Dead

N(%)

           

Stroke Impact Scale (SIS)

Strength

Q2(Q1,q3)

           

Hand ability

Q2(Q1,q3)

           

Mobility

Q2(Q1,q3)

           

Motor

Q2(Q1,q3)

           

Daily activities

Q2(Q1,q3)

           

Physical function

Q2(Q1,q3)

           

Memory

Q2(Q1,q3)

           

Communication

Q2(Q1,q3)

           

Emotion

Q2(Q1,q3)

           

Participation

Q2(Q1,q3)

           

Recover (VAS)

Q2(Q1,q3)

           

Motor score derived from three domains (arm, hand, leg and foot strength; hand function and mobility)

Q2(Q1,q3)

           

Physical function score derived from four domains (arm, hand, leg and foot strength; hand function; mobility; Daily activities)

Q2(Q1,q3)

           

Vitality

 

Q2(Q1,q3)

           

Mood

MHI in FOCUS and EFFECTS

PHQ-9 in AFFINITY

MADRS in EFFECTS

Q2(Q1,q3)

           

EQ5D-5L

 

Q2(Q1,q3)

           

Adverse events

Any stroke

N(%)

           

All thrombotic events

N(%)

           

Ischaemic stroke

N(%)

           

Other thrombotic events

N(%)

           

Acute coronary events

N(%)

           

All bleeding events

N(%)

           

Haemorrhagic stroke

N(%)

           

Upper GI bleed

N(%)

           

Other major bleeds

N(%)

           

Epileptic seizures

N(%)

           

Fall with injury

N(%)

           

Fractured bone

N(%)

           

Hyponatraemia

N(%)

           

Hyperglycaemia

N(%)

           

Symptomatic hypoglycaemia

N(%)

           

New depression

N(%)

           

New antidepressant

N(%)

           

Attempted or actual suicide

N(%)

           

Living circumstances

Own home

N(%)

           

Relatives

N(%)

           

Care/nursing home

N(%)

           

Long term NHS

N(%)

           

In hospital

N(%)

           

Other

N(%)

           
  1. Abbreviations: EQ5D-5L EuroQol 5 dimension questionnaire—five level, GI gastrointestinal, MADRS Montgomery-Åsberg Depression Rating Scale, MHI Mental Health Inventory, NHS National Health Service, PHQ-9 Patient Health Questionnaire 9-item, VAS visual analogue scale
  2. Plot similar to this with all trials and an overall effect (one-stage IPDM) View full size image