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Table 2 How summary results can obscure situations where the typical patient receives no benefit or risks net harm

From: Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

Assumption: Treatment reduces baseline risk by 25% but with a cost of 2 serious treatment-related adverse events per 1,000 patients per year

 

Control Event Rate

(CER, %)

Experimental Event Rate

(EER, %)

Relative Risk Reduction (RRR)

Absolute Risk Reduction

(ARR)

Number Needed to Treat (NNT)

   (% of study population)

Results over 5 years

Scenario #1

     

Overall result (100%)

8

7

0.125

0.01

100

   Average risk subjects (75%)

4

4

0

0

∞

   High risk subjects (25%)

20

16

0.2

0.04

20

Scenario #2

     

Overall result (100%)

9

7.75

0.14

0.0125

80

   Average risk subjects (75%)

2

2.5

-0.25†

-0.005†

-200

   High risk subjects (25%)

30

23.5

0.22

0.065

15

  1. † The minus sign denotes that treatment had net harm, rather than benefit.