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Novartis Reply to the ATMOSPHERE Data Monitoring Committee
by
Tougas, Gervais
, Aftring, R. Paul
in
Amides - adverse effects
/ Astronauts
/ Clinical trials
/ Clinical Trials Data Monitoring Committees
/ Diabetes
/ Diabetes Mellitus, Type 2 - drug therapy
/ Fumarates - adverse effects
/ Heart diseases
/ Heart failure
/ Humans
/ Randomized Controlled Trials as Topic
2016
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Novartis Reply to the ATMOSPHERE Data Monitoring Committee
by
Tougas, Gervais
, Aftring, R. Paul
in
Amides - adverse effects
/ Astronauts
/ Clinical trials
/ Clinical Trials Data Monitoring Committees
/ Diabetes
/ Diabetes Mellitus, Type 2 - drug therapy
/ Fumarates - adverse effects
/ Heart diseases
/ Heart failure
/ Humans
/ Randomized Controlled Trials as Topic
2016
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Novartis Reply to the ATMOSPHERE Data Monitoring Committee
by
Tougas, Gervais
, Aftring, R. Paul
in
Amides - adverse effects
/ Astronauts
/ Clinical trials
/ Clinical Trials Data Monitoring Committees
/ Diabetes
/ Diabetes Mellitus, Type 2 - drug therapy
/ Fumarates - adverse effects
/ Heart diseases
/ Heart failure
/ Humans
/ Randomized Controlled Trials as Topic
2016
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Novartis Reply to the ATMOSPHERE Data Monitoring Committee
Journal Article
Novartis Reply to the ATMOSPHERE Data Monitoring Committee
2016
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Overview
To the Editor:
The Sounding Board article by Swedberg and colleagues,
1
now published in the
Journal,
describes the experience of the data monitoring committee of the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE) as data from other trials of aliskiren raised questions regarding a possible risk to participants in ATMOSPHERE.
2
Novartis, as the sponsor of ATMOSPHERE, had engaged the independent data monitoring committee, which was composed of respected experts, to oversee the participants’ safety in this trial through periodic reviews of unblinded safety and efficacy data. During the course of the trial, the data monitoring committee, . . .
Publisher
Massachusetts Medical Society
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