4 ms·

They don't report whether that difference was significant though, do they...

by aheilbut 13y ago

DanBC 13y ago
(fpgeek is right, I should have read further) It was significant enough to stop the trial. (http://www.ncbi.nlm.nih.gov/pubmed/19570573?dopt=Abstract http://www.ncbi.nlm.nih.gov/pubmed/19570573?dopt=Abstract) > FINDINGS: At the second interim analysis, the hazard ratio for mortality in patients on interferon gamma-1b showed absence of minimum benefit compared with placebo (1.15, 95% CI 0.77-1.71, p=0.497), and indicated that the study should be stopped. After a median duration of 64 weeks (IQR 41-84) on treatment, 80 (15%) patients on interferon gamma-1b and 35 (13%) on placebo had died. Almost all patients reported at least one adverse event, and more patients on interferon gamma-1b group had constitutional signs and symptoms (influenza-like illness, fatigue, fever, and chills) than did those on placebo. Occurrence of serious adverse events (eg, pneumonia, respiratory failure) was similar for both treatment groups. Treatment adherence was good and few patients discontinued treatment prematurely in either group.
- aheilbut 13y ago
  My point is that by saying that "more patients on the drug died", they're implying that the drug was itself killing people. With 35 patients, the 2% difference is about one person. They stopped the trial because the drug wasn't doing anything, but it's misleading to suggest that it was contributing further to mortality.
  - fpgeek 13y ago
    I don't think they are. I think I may have cut my quote in a bad place from that perspective. They continue: "That was the death knell for the drug. Most insurers stopped paying for it." I don't think they're implying that the drug killed people. I think they're saying that the study made it obvious it wasn't helping, so insurers stopped covering it and other consequences followed.

4 ms·

They don't report whether that difference was significant though, do they...

by aheilbut 13y ago

They don't report whether that difference was significant though, do they...

DanBC 13y ago
(fpgeek is right, I should have read further) It was significant enough to stop the trial. (http://www.ncbi.nlm.nih.gov/pubmed/19570573?dopt=Abstract http://www.ncbi.nlm.nih.gov/pubmed/19570573?dopt=Abstract) > FINDINGS: At the second interim analysis, the hazard ratio for mortality in patients on interferon gamma-1b showed absence of minimum benefit compared with placebo (1.15, 95% CI 0.77-1.71, p=0.497), and indicated that the study should be stopped. After a median duration of 64 weeks (IQR 41-84) on treatment, 80 (15%) patients on interferon gamma-1b and 35 (13%) on placebo had died. Almost all patients reported at least one adverse event, and more patients on interferon gamma-1b group had constitutional signs and symptoms (influenza-like illness, fatigue, fever, and chills) than did those on placebo. Occurrence of serious adverse events (eg, pneumonia, respiratory failure) was similar for both treatment groups. Treatment adherence was good and few patients discontinued treatment prematurely in either group.
- aheilbut 13y ago
  My point is that by saying that "more patients on the drug died", they're implying that the drug was itself killing people. With 35 patients, the 2% difference is about one person. They stopped the trial because the drug wasn't doing anything, but it's misleading to suggest that it was contributing further to mortality.
  - fpgeek 13y ago
    I don't think they are. I think I may have cut my quote in a bad place from that perspective. They continue: "That was the death knell for the drug. Most insurers stopped paying for it." I don't think they're implying that the drug killed people. I think they're saying that the study made it obvious it wasn't helping, so insurers stopped covering it and other consequences followed.