1 / 13

BD011

Table 10 Summary of the Change of IPN Volume, Calories, and Frequency during the Follow-up Period (Week 6 to Week 18), with the Treatment (Week 2 to Week 6) as the Covariate, for the ITT Population by Treatment Group.

tomas
Download Presentation

BD011

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Table 10Summary of the Change of IPN Volume, Calories, and Frequency during the Follow-up Period (Week 6 to Week 18), with the Treatment (Week 2 to Week 6) as the Covariate, for the ITT Population by Treatment Group *P-values were determined from Bonferroni t-test following rank ANCOVA with the rank of the difference between Week 6 and Week 2 as the covariate. † Values shown are the median changes. BD011

  2. Weaning Criteria 1:Ability to Hydrate positive enteral balance(enteral fluid intake [mL] - volume of stool output [mL])  ~ 500 mL/d and/or urine volume  0.5 mL/kg/h over 24 h or ~ 75% of calculated minimum urine volumeprior to nighttime infusion EF167

  3. Weaning Criteria 2:Maintaining Normal Electrolytes Serum Sodium 135 - 146 mEq/L Serum Potassium 3.5 - 4.7 mEq/L Serum Bicarbonate 19 - 25 mEq/L EF168

  4. Weaning Criteria 3:Ability to Sustain an Appropriate Body Weight Maintenance of total body water (relatively stable BIA) or An ability to gain body weight while maintainingtotal body water (relatively stable BIA) and An ability to consistently consume orally 80% to 100%of estimated total caloric requirements(corrected for malabsorption)as calculated from standard equations EF169

  5. IMP20317 (Final) (1 of 2)_CC1Components of the Key Efficacy Endpoint Total IPN Volume (L/week) – ITT Population EF208

  6. IMP20317 (Final) (2 of 2)_CC2Components of the Key Efficacy Endpoint Total IPN Volume (L/week) – ITT Population EF209

  7. FDA minutes of August 22, 2000 meeting (teleconference) “The Division advised the sponsor that there is no statistical requirement concerning a minimum number of patients per center. If they are able to find another site that can enroll fewer patients than the sponsor's current goal of 10 patients per center, the issue of statistical analysis can be worked through by modeling, combining center, etc.” EF146

  8. July 2001– FDA teleconference (Excerpt from Sponsor record) S. Malozowski summarized the discussion by saying that reaching a p-value of 0.05 based on data from two centers would likely be considered a “win” by the Agency while submission of a file based on data from a single center would involve some level of risk. EF147

  9. Body Weight (kg): Week 0 vs. Week 18 P = ns for rhGH + SOD vs. SOD (GLN) and for rhGH = SOD (GLN) vs. SOD (GLN) EF173

  10. Table 3.4.16 (1 of 2)Summary of Weight (kg) by Week(Safety Population) SAF064

  11. Table 3.4.16 (2 of 2)Summary of Weight (kg) by Week(Safety Population) Listings of Vital Signs Data - Values and Change from Baseline in Appendix 16.2.8.4 and Body Weight - Values and Change from Baseline in Appendix 16.2.8.5. SAF065

  12. Diet Parameter:Resistance (BIA, average ohms/day) 1 P-value is from Dunnett’s t-test EF219

  13. Table 2.1.1Summary of Hydration Fluid Intake (mL)Per Week over Time (ITT Population) – All Sites Listing of Derived Hydration Fluid, Urine Output, and Stool Output by Week in Appendix 16.2.6.11 EF017

More Related