Primary endpoint: change in LVESVI from baseline to 8 months

Jul 02, 2012

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Primary endpoint: change in LVESVI from baseline to 8 months

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Presentation Transcript

Statistical Review of P040049 Acorn’s CorCap Cardiac Support Device

Statistical Review of P040049 Acorn’s CorCap Cardiac Support Device. Laura Thompson, Ph.D. Mathematical Statistician CDRH/FDA. Outline. Study Design Primary Endpoint Analysis Concerns Separate Analyses of Components of Primary Endpoint Analyses of Secondary Endpoints

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Statistical Research on APBD

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DIABETES trial

DIABETES trial. 149 patients with type 2 diabetes (1/3 on insulin) and native coronary lesions appropriate for stent implantation . Cypher sirolimus-eluting stent. Bare-metal stent. Primary Endpoint: In-stent and late lumen loss at 9 months (determined by QCA) Secondary Endpoints:

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Pilot Study in Metastatic Breast Cancer of Diurnal Cortisol Variability, Mood and Muscle Strength Associated with a 12-

At baseline and endpoint, subjects participated in semi-structured interviews focusing on their experiences with illness, medical treatment, CAM therapies and (at endpoint) with qigong, Interviews were analyzed to understand patients' motivations for joining the study, as well as their narratives o

129 views • 3 slides

The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies

Day 1. Day 23 (Steady State). Mean Change from Baseline QTc (msec). Mean Plasma Dofetilide Concentration (ng/mL). Δ QTc (95% CI) =. Probability of NSR (95% CI) =. Probability of Remaining in NSR at 6 months (%) . QTc Change from Baseline at Steady State (msec). Dofetilide 125 mcg BID.

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Change in Posterior-Wall Mean CIMT

Change in Posterior-Wall Mean CIMT. Glimepiride. Pioglitazone. LS Mean Change from Baseline, mm. Baseline. 24. 48. 72. Week. No. of Observations Glimepiride Pioglitazone. 186 175. 170 166. 186 175. 186 175. Mazzone T et al. JAMA 2006;296:2572-2581.

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Stages of Change: Primary Tasks

1. Precontemplation Definition: Not yet considering change or is unwilling or unable to change. Primary Task: Raising Awareness. 6. Recurrence Definition: Experienced a recurrence of the symptoms. Primary Task: Cope with consequences and determine what to do next.

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Introduction to CEM Primary

Introduction to CEM Primary. Dr Chris Jellis Research Associate CEM. What Will W e C over?. What makes a good baseline assessment? The concept of Developed Ability Adaptive assessments CEM Primary assessments. What is a Baseline Assessment?.

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Not baseline: ASIC, DCFEB R&D if L1A latency > 10 m s

Not baseline: ASIC, DCFEB R&D if L1A latency > 10 m s . At Phase 2 baseline 10 m s and 500 kHz lose ~1% of cathode data, beyond that need to replace DCFEBs 13.8 MChF , 8 months steady crane use

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Progression as an endpoint in CRC

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Mean Responses on PGI-Improvement Primary Endpoint at Week 12

Duloxetine. Placebo. Mean Responses on PGI-Improvement Primary Endpoint at Week 12. Very much better 1. Much better 2. ***. ***. ***. ***. A little better 3. No change 4. 2. 4. 8. 12. A little worse 5. Week of Study. Much worse 6.

132 views • 3 slides

Baseline

BTR 4.2%. BTR 3.4%. BTR 3.4%. WTR = 3.3-8.3 mmol/L, 60-150 mg/dL. Baseline. 3 Months. 6 Weeks. p = 0.035 for change from baseline to 3 months in WTR and ATR or ATR >240 mg/dl. Legend to the figure:

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Process Study 24-Month Results

Process Study 24-Month Results. October 1, 2008 (abridged). Study Design for Primary Endpoint (≥ 50% Reduction in Leg Pain (VAS) at 6 Months). PROCESS Study Summary of ITT Results Until 6 Months (Kumar K et al. Pain 2007). Patients in the SCS and CMM groups were: Well matched

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Introduction:

% change of MADRS (week 4 vs. baseline). Responders Non-responders. change of prefrontal cordance values (week 1 vs. baseline).

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Baseline 2 Update

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Statistical Review of P040049 Acorn’s CorCap Cardiac Support Device

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Primary outcome (%)

Cumulative incidence of primary endpoint with intensive vs. standard lipid-lowering in treatment-resistant hypertension. Atorvastatine 10 mg. 30. Atorvastatine 80 mg.

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NOTHING new without baseline data!

NOTHING new without baseline data!. The Change Process always includes a way to know if change results in improvement.

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Primary outcome (%)

Atorvastatine 10 mg. Cumulative incidence of primary endpoint with intensive vs. standard lipid-lowering in treatment-resistant hypertension. 30. Atorvastatine 80 mg.

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Primary endpoint: change in LVESVI from baseline to 8 months

Primary endpoint: change in LVESVI from baseline to 8 months

Presentation Transcript

Statistical Review of P040049 Acorn’s CorCap Cardiac Support Device

Statistical Research on APBD

DIABETES trial

Pilot Study in Metastatic Breast Cancer of Diurnal Cortisol Variability, Mood and Muscle Strength Associated with a 12-

The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies

Change in Posterior-Wall Mean CIMT

Stages of Change: Primary Tasks

Introduction to CEM Primary

Not baseline: ASIC, DCFEB R&amp;D if L1A latency &gt; 10 m s

Progression as an endpoint in CRC

Mean Responses on PGI-Improvement Primary Endpoint at Week 12

Baseline

The Evolution of Endpoint Security: Detecting and Responding to Malware Across the Kill Chain

Process Study 24-Month Results

Introduction:

Drive to Collab Endpoint Refresh Program

Baseline 2 Update

Statistical Review of P040049 Acorn’s CorCap Cardiac Support Device

Primary outcome (%)

Securing the endpoint

NOTHING new without baseline data!

Primary outcome (%)

Not baseline: ASIC, DCFEB R&D if L1A latency > 10 m s