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Clinical Trial Data Analysis and Rates

The document summarizes data from a clinical trial comparing drug A to a placebo. It provides probabilities, risk ratios, and numbers needed to treat related to headaches. The absolute risk reduction for headaches with drug A was 11.9%. The odds ratio indicated those taking drug A had 11.9% greater risk of headaches than the placebo group. Various health metrics like mortality rates were also calculated using population data.

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Bee Anne Biñas
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0% found this document useful (0 votes)
699 views5 pages

Clinical Trial Data Analysis and Rates

The document summarizes data from a clinical trial comparing drug A to a placebo. It provides probabilities, risk ratios, and numbers needed to treat related to headaches. The absolute risk reduction for headaches with drug A was 11.9%. The odds ratio indicated those taking drug A had 11.9% greater risk of headaches than the placebo group. Various health metrics like mortality rates were also calculated using population data.

Uploaded by

Bee Anne Biñas
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

BINAS, RHOBEE ANNE

BSN – 2BS

09 Module 2 - Check-in Activity 3

In numbers 1-8, refer to the data below. This table describes results from a clinical trial
of drug A. Some subjects were treated with Drug A while others were given a placebo;
then headache events were recorded.

  Headache No Headache

Drug A 117 617

Placebo 29 696

1. Is the study retrospective or prospective?

PROSPECTIVE

2. For those in the Drug A treatment group, find the probability that the subject
experienced a headache.

117 117
P(E1) = = = 0.159
117+617 734

3. Compare P(headache|Drug A) and P(headache|placebo).

117 117
P ( headache / Drug A) = = = 0.159
117+617 734

29 29
P (headache / Placebo) = = = 0.04
29+696 725

4. Find the value of the absolute risk reduction for headaches in the treatment
and placebo groups.

Absolute Risk Reduction = P ( headache / Drug A) - P (headache / Placebo)

= 0.159 – 0.04
= 0.119

5. Find the number of Drug A users that would need to stop using Drug A in
order to prevent a single headache.

1
NUMBER OF NEEDED TO TREAT =
ABSOLUTE RISK REDUCTION

1
=
0.119

= 8.40 or 9

6. For those in the Drug A treatment group, find the odds in favor of a headache,
then find the odds against a headache.

P ( HEADACHES)
ODDS IN FAVOR =
P ( HEADACHES)

0.159
=
0. 841

= 159 :841

ODDS AGAINST = 841:159

7. Find the odds ratio for headaches in the treatment group compared to the
placebo group, then interpret the result. Should Drug A users be concerned
about headaches as an adverse reaction?

For the treatment group there is an absolute risk reduction of 0.119 as compared to the
subjects in placebo treatment group there are 11.9% greater events of headaches when the
subject is treated with Drug A than for the subjects given a placebo.

 
For numbers 8-15, use the data in the next table to find the indicated rates. Round
results to one decimal place and use a multiplying factor of k = 1000 unless indicated
otherwise.

Population: 312,799,495 Deaths: 2,515,458

Women aged 15-44: 61,488,227 Motor vehicle deaths: 33,783

Live births: 3,953,590 Fetuses delivered without life after 20


weeks of gestation: 26,148

Deaths of infants under 1 year of age: Deaths of infants under 28 days of age:
23,910 15,973

HIV-infected persons: 1,155,792 Deaths

8. Find the neonatal mortality rate.

15, 973
NMR = 3, 953, 590 X 1000

= 4.0

9. Find the fetal mortality rate.

# of fetal death of 20 weeks of gestation


FMR = X 1000
# of live birth + # of fetal death of 20 weeks
of gestation
26,148
FMR = X 1000
3, 953, 590 + 26, 148

= 6.6 OR
= 7

1O. Find the perinatal mortality rate.

6.6
26, 148 / 26, 148 + 3, 953, 590 X 1000 = 6.57

11. Find the crude birth rate.

12.6
3,953, 590 / 312, 755, 495 X 1000 = 12.6

12. Find the general fertility rate.

64.3
(312, 799, 495 / 61,488, 227) X 1000 = 64.3

13. Using a multiplier of k = 100,000, find the motor vehicle death incidence rate.

10.8 cases per 100,000 population


33,783 / 312, 799, 495 X 1000 = 10.8

14. Find the HIV infection prevalence rate.

3.7
1,115,793 /312,799,495 X 1000 = 3.69
15. Find the HIV infection mortality rate for HIV-infected persons.

NO DATA GIVEN

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