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Table 3 Adverse and serious adverse events

From: Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

 

Intervention group (n = xxx)

Control group (n = xxx)

p-value

Serious adverse events

 Total

nEVT/nPAT (%)

nEVT/nPAT (%)

p = 0.xxx

 Adverse event Aa

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Adverse event Ba

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Adverse event Ca

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Etc.a

nEVT/nPAT (%)

nEVT/nPAT (%)

 

Adverse events

 Total

nEVT/nPAT (%)

nEVT/nPAT (%)

p = 0.xxx

 Adverse event Aa

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Adverse event Ba

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Adverse event Ca

nEVT/nPAT (%)

nEVT/nPAT (%)

 

 Etc.a

nEVT/nPAT (%)

nEVT/nPAT (%)

 
  1. aExample categories which will be revised based on observation of final free-text data responses