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In a recent clinical trial a comparison was done to assess the rates of certain

ID: 3129871 • Letter: I

Question

In a recent clinical trial a comparison was done to assess the rates of certain adverse side effects for a group taking an experimental drug versus those in a control group. In this study, 148 participants received the experimental drug and 294 subjects received a placebo. A table summarizing the results of this study is provided below.

For each of the adverse side effects studied, calculate the relative risk for that effect when taking the drug versus taking the placebo. In addition, report the percent change in risk associated with each relative risk.
Use 3 decimal place precision for your answers

Headache side effect:
Relative risk =
% change in risk =

Nausea side effect:
Relative risk =
% change in risk =   

Insomnia side effect:
Relative risk =
% change in risk =

Headache Nausea Insomnia yes no yes no yes no Drug 27 121 31 117 19 129 Placebo 21 273 26 268 3 291

Explanation / Answer

In a recent clinical trial a comparison was done to assess the rates of certain adverse side effects for a group taking an experimental drug versus those in a control group. In this study, 148 participants received the experimental drug and 294 subjects received a placebo. A table summarizing the results of this study is provided below.

Headache

Nausea

Insomnia

yes

no

yes

no

yes

no

Drug

27

121

31

117

19

129

Placebo

21

273

26

268

3

291

For each of the adverse side effects studied, calculate the relative risk for that effect when taking the drug versus taking the placebo. In addition, report the percent change in risk associated with each relative risk.
Use 3 decimal place precision for your answers

Relative risk = (A/{A+C})/(B/{B+D})

Headache side effect:

Absolute risk in treatment group

0.182

Absolute risk in control group

0.071

Relative risk (RR)

2.554


% increase = (RR - 1) x 100
% change in risk = 1.554*100=155.4 % increase

Nausea side effect:

Absolute risk in treatment group

0.209

Absolute risk in control group

0.088

Relative risk (RR)

2.369


Absolute risk reduction (ARR)

-0.121


% change in risk =   1.369*100=136.9% increase

Insomnia side effect:

Absolute risk in treatment group

0.128

Absolute risk in control group

0.010

Absolute risk reduction (ARR)

-0.118

Relative risk (RR)

12.581


11.581*100 =1158.1% increase

Headache

Nausea

Insomnia

yes

no

yes

no

yes

no

Drug

27

121

31

117

19

129

Placebo

21

273

26

268

3

291

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