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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)