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Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right- sided colon cleansing: a randomized controlled phase 3 trial versus.

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Presentation on theme: "Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right- sided colon cleansing: a randomized controlled phase 3 trial versus."— Presentation transcript:

1 Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right- sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate  Michael P. DeMicco, MD, FACG, ABAM, Lucy B. Clayton, MSc, FRSC, Jeff Pilot, BSc, PhD, Michael S. Epstein, MD, FACG, AGAF Pradeep Kumar T. Bekal, Michael DeMicco, Michael Epstein, Robert Hardi, Wayne L. Harper, Joseph B. Henderson, Vipul Jairath, Thomas E. Jarrett, Kenneth L. Kelln, Sayed S. Khatami, Gina S. Kwak, Barrett Levesque, Mahmoud Mosli, Walter Reinisch, Mariam S. Sauer, Mark Silverberg, Kenneth E. Smith Michael P. DeMicco, MD, FACG, ABAM, Lucy B. Clayton, MSc, FRSC, Jeff Pilot, BSc, PhD, Michael S. Epstein, MD, FACG, AGAF Pradeep Kumar T. Bekal, Michael DeMicco, Michael Epstein, Robert Hardi, Wayne L. Harper, Joseph B. Henderson, Vipul Jairath, Thomas E. Jarrett, Kenneth L. Kelln, Sayed S. Khatami, Gina S. Kwak, Barrett Levesque, Mahmoud Mosli, Walter Reinisch, Mariam S. Sauer, Mark Silverberg, Kenneth E. Smith  Gastrointestinal Endoscopy  Volume 87, Issue 3, Pages e3 (March 2018) DOI: /j.gie Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

2 Gastrointestinal Endoscopy 2018 87, 677-687. e3DOI: (10. 1016/j. gie
Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

3 Figure 1 Study plan. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

4 Figure 2 Patient disposition. *Patients could be excluded from the PP set for more than 1 reason. FAS, Full analysis set; mFAS, modified full analysis set; PP, per protocol. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

5 Figure 3 Efficacy in bowel cleansing using the Harefield Cleansing Scale, including overall bowel cleansing success and high-quality cleansing of the ascending colon plus cecum (mFAS). CL, one-sided 97.5% lower confidence limit; Δ, difference in rate versus trisulfate. *P values calculated by post hoc analysis. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

6 Figure 4 Efficacy in bowel cleansing using the Boston Bowel Preparation Scale (supportive secondary endpoint, modified full analysis set). *Successful overall bowel cleansing was a score of ≥6 overall and score ≥2 in each bowel segment. P values calculated by post hoc analysis. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

7 Figure 5 Lesion detection (modified full analysis set). ADR, adenoma detection rate; CL, one-sided 97.5% lower confidence limit; PDR, polyp detection rate; Δ, difference in rate versus trisulfate. *P values calculated by post hoc analysis. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

8 Supplementary Figure 1 Sensitivity analyses of bowel-cleansing efficacy in the full analysis set (A) and per protocol set (B). CL, one-sided 97.5% lower confidence limit; Δ, difference in rate versus trisulfate. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions

9 Supplementary Figure 2 Subgroup analyses of bowel-cleansing efficacy according to patient age. P values calculated by post hoc analysis. Gastrointestinal Endoscopy  , e3DOI: ( /j.gie ) Copyright © 2018 American Society for Gastrointestinal Endoscopy Terms and Conditions


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