Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis. (Q34602212)

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:19095197%20AND%20SRC:MED&resulttype=core&format=json

18 January 2020

title

Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis (English)

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18 January 2020

0 references

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2

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18 January 2020

author name string

Daniele Poole

series ordinal

1

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https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:19095197%20AND%20SRC:MED&resulttype=core&format=json

18 January 2020

Silvio Garattini

series ordinal

3

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18 January 2020

publication date

1 January 2009

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18 January 2020

number of pages

6

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Lancet Infectious Diseases

inferred from page(s)

published in

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18 January 2020

volume

9

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18 January 2020

issue

1

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18 January 2020

page(s)

67-72

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Making medicines safer--the need for an independent drug safety board.

18 January 2020

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Efficacy and safety of recombinant human activated protein C for severe sepsis

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Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death

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Drotrecogin alfa (activated): does current evidence support treatment for any patients with severe sepsis?

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Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment*

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The Problems and Challenges of Immunotherapy in Sepsis*

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Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: data from the PROWESS trial

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Increasing evidence that the risks of rhAPC may outweigh its benefits.

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Risk and the efficacy of antiinflammatory agents: retrospective and confirmatory studies of sepsis

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7 January 2021

Risks and benefits of activated protein C treatment for severe sepsis

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Outcome prediction for individual intensive care patients: useful, misused, or abused?

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Subgroup analysis and other (mis)uses of baseline data in clinical trials

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Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials

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The revised CONSORT statement for reporting randomized trials: explanation and elaboration

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Hospital mortality and resource use in subgroups of the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial

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Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems

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Looking at subgroups in an inhomogeneous population does not make these subgroups more homogeneous

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Prescribing indications based on successful clinical trials in sepsis: a difficult exercise

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Statistics notes. Interaction 2: Compare effect sizes not P values

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Multiple significance tests: the Bonferroni method

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What's wrong with Bonferroni adjustments

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7 January 2021

Activated protein C: do more survive?

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Reassessing recombinant human activated protein C for sepsis: time for a new randomized controlled trial

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7 January 2021

Drotrecogin Alfa (Activated) in Severe Sepsis

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7 January 2021

Early goal-directed therapy in the treatment of severe sepsis and septic shock

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7 January 2021

New strategies for clinical trials in patients with sepsis and septic shock

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7 January 2021

Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated)

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7 January 2021