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A total of 96 patients in the bardoxolone methyl group?

 
 
Reply Sun 10 Nov, 2013 08:34 pm

But it says in beginning "A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl." 69 or 96?


Context:

Results
The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P<0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group.

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MOre:
http://www.nejm.org/doi/full/10.1056/NEJMoa1306033?query=featured_home
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Type: Question • Score: 2 • Views: 690 • Replies: 3
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Miller
 
  1  
Reply Sun 10 Nov, 2013 09:18 pm
If this is a typographical error, the NEJM will publish a correction at a later date.
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MontereyJack
 
  1  
Reply Sun 10 Nov, 2013 09:51 pm
I think it's saying there were 1088 patients who were given b methyl and also 1088 different patients who were given a placebo, and then gives the different outcomes for specific conditions in each group--primary composite and ESRD, whatever those are, and heart failure. I think they're saying heart failure was statistically significantly more common in the b methy group than in the placebo group. Yeah, probability less than .001 that it could happen by chance. Both 69 and 96 can be correct (assuming they did their calculations right) because they're talking about two different conditions.
oristarA
 
  1  
Reply Mon 11 Nov, 2013 04:15 am
@MontereyJack,
MontereyJack wrote:

I think it's saying there were 1088 patients who were given b methyl and also 1088 different patients who were given a placebo, and then gives the different outcomes for specific conditions in each group--primary composite and ESRD, whatever those are, and heart failure. I think they're saying heart failure was statistically significantly more common in the b methy group than in the placebo group. Yeah, probability less than .001 that it could happen by chance. Both 69 and 96 can be correct (assuming they did their calculations right) because they're talking about two different conditions.


Thank you Jack.
But how to understand "assigned"? "A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl," that is, the b methyl group had had only a total of 69 patients.
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