Nutritional Adequacy Therapeutic Enhancement in the Criti... | NCT01934192 | Trialant
NCT01934192
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Dec 11, 2017Actual
Enrollment
91Actual
Phase
Phase 2
Conditions
Gastroparesis
Interventions
GSK962040 50 mg
Metoclopramide 10 mg
Placebo NG
Placebo IV
Countries
United States
Australia
Canada
Protocol Section
Identification Module
NCT ID
NCT01934192
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
113445
Secondary IDs
Not provided
Brief Title
Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study
Official Title
NUTRItional Adequacy Therapeutic Enhancement in the Critically Ill: A Randomized Double Blind, Placebo-controlled Trial of the Motilin Receptor Agonist GSK962040. The NUTRIATE Study
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 4, 2014Actual
Primary Completion Date
Jul 8, 2016Actual
Completion Date
Jul 8, 2016Actual
First Submitted Date
Aug 29, 2013
First Submission Date that Met QC Criteria
Aug 29, 2013
First Posted Date
Sep 4, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 6, 2017
Results First Submitted that Met QC Criteria
Oct 9, 2017
Results First Posted Date
Nov 9, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 9, 2017
Last Update Posted Date
Dec 11, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gastric emptying in this population; and provide preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics upon repeat dosing in a critically ill population.
After meeting eligibility criteria, male and female subjects will be randomized to either receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive), study treatments will switch such that those originally receiving GSK962040 will receive metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if subjects develop intolerance prior to any treatment, they will be randomized to receive either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).
The study will consist of a screening/baseline assessment, a treatment period (up to 7 days in duration), and a 4-day post treatment safety follow-up assessment. The duration of each subject's participation in the study from screening to follow-up safety assessment will be up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to the ICU.
Detailed Description
Not provided
Conditions Module
Conditions
Gastroparesis
Keywords
tolerability
camicinal
single dose
acetaminophen
gastric emptying
critically ill
GSK962040
pharmacokinetics
pharmacodynamics
gut motility
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
91Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Initial randomization: GSK962040 Arm
Experimental
Subjects in the GSK962040 Arm will receive 50 mg once daily enteral dose administered through NG tube up to 7 days.
Drug: GSK962040 50 mg
Initial randomization: Placebo Arm
Placebo Comparator
Subjects in the placebo arm will receive once daily dose enteral dose administered through NG tube up to 7 days.
Drug: Placebo NG
Treatment change due to intolerance: GSK962040 Arm
Experimental
Subjects that develop intolerance and that originally received Placebo will receive 50 mg once daily enteral dose administered through NG tube + placebo IV
Drug: GSK962040 50 mg
Drug: Placebo IV
Treatment change due to intolerance: Metoclopramide Arm
Active Comparator
Subjects that develop intolerance and that originally received GSK962040 will receive metoclopramide 10 mg IV every 6 h + placebo NG
Drug: Metoclopramide 10 mg
Drug: Placebo NG
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK962040 50 mg
Drug
GSK962040 50 mg will be administered once daily enteral dose through NG tube up to 7 days.
Initial randomization: GSK962040 Arm
Treatment change due to intolerance: GSK962040 Arm
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.
Up to Day 7
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Up to Day 7
Secondary Outcomes
Measure
Description
Time Frame
Average Percentage Goal Calories Delivered Prior to Development of Intolerance
The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age & Gender: Male or female between 18 and 85 years of age inclusive, at the time of obtaining the informed consent.
First admitted to participating ICU within the previous 48 hours.
Intubated and invasively mechanically ventilated
Indicated to receive early EN or are already receiving EN (subject must be on EN prior to receiving study treatment)
Have at least one of the following
Clinical evidence of cardiovascular dysfunction defined as the need for vasopressor agents (e.g. norepinephrine, epinephrine, vasopressin), >5 microgram/kg/min of dopamine, or >/= 50 microgram/min phenylephrine) for greater than or equal to 2 hours;
Poly-trauma with an injury severity score (ISS) >=15 points
Acute traumatic or non-traumatic brain injury Glasgow Coma Scale (GCS) <=12, prior to the initiation of sedation.
Exclusion Criteria:
Subjects who are not expected to be in the ICU and alive for at least 48 hrs from point of screening.
Subjects with acute hepatitis (e.g. acute hepatitis B or C) or severe chronic liver disease (e.g. Child Pugh class C cirrhosis) will be excluded
Liver function tests: If Alanine aminotransferase (ALT) >=8x upper limit of normal (ULN); OR If ALT >5-8x ULN and bilirubin >2<=3 ULN or bilirubin >3x ULN (Include only if bilirubin <1.5xULN); OR If ALT <=5xULN and Bilirubin >3xULN (Include only if ALT <=3xULN and Bilirubin >2 <=3xULN)
Subjects who have received a gastric prokinetic agent in the previous 12 hours (e.g., erythromycin, azithromycin, metoclopramide, domperidone).
QT duration corrected for heart rate (QTc) >480 ms. QTcF is the recommended correction factor for all sites. If QT duration corrected for heart rate by Fridericia's formula (QTcF) is not possible to obtain or calculate, QT duration corrected for heart rate by Bazett's formula (QTcB) or machine or manual over read, may be obtained after consultation with the medical monitor. The QT correction formula used to determine inclusion and discontinuation should be the same throughout the study.
Use of strong Cyp3A4 inhibitors
Subjects who require renal replacement therapy or with an estimated glomerular filtration rate (GFR) of <30 mL/min byCockroft-Gault calculation).
Subjects who have a history of or who have undergone major esophageal or gastric surgery on this admission (major lower abdominal surgery will not result in exclusion unless this carries a contraindication to enteral feeding).
Subjects with an absolute contraindication to enteral nutrition e.g. subjects with ongoing bowel obstruction or perforation.
Subject has a gastric pacemaker
Pregnant or lactating females
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Concurrent enrollment in other interventional study involving a novel (i.e.unapproved or experimental) chemical or biopharmaceutical entity.
Previous randomization in this study
Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
Exclusion to re-randomization:
Subjects with an untreated pheochromocytoma.
Subjects with a past history of a seizure disorder (e.g., epilepsy) and is currently receiving anti-epileptic treatment for their seizure disorder, ongoing refractory, or sustained seizure disorder (prophylactic use for head injury/isolated new seizure maintained on anti-seizure meds in ICU acceptable).
Subjects taking drugs likely to cause extrapyramidal reactions.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Aurora
Colorado
80045
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a screening phase, a treatment period of up to 7 days and a post treatment safety follow-up of 14 days after the last dose of study medication. After performing Baseline tests eligible participants were included in the study.
Recruitment Details
A total of 92 participants between 18 to 85 years of age who were admitted to Intensive Care Unit (ICU), mechanically ventilated and who received enteral nutrition (EN) were included in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Baseline EN Tolerant: Placebo/Camicinal
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Metoclopramide 10 mg
Drug
Metoclopramide will be administered IV every 6 h
Treatment change due to intolerance: Metoclopramide Arm
Placebo NG
Drug
Matching placebo once daily enteral dose will be administered through NG tube up to 7 days
Initial randomization: Placebo Arm
Treatment change due to intolerance: Metoclopramide Arm
Placebo IV
Drug
Placebo will be administered IV every 6 hours
Treatment change due to intolerance: GSK962040 Arm
Up to Day 7
Average Percentage Goal Protein Delivered Prior to Development of Intolerance
The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Up to Day 7
Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance
Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.
Up to Day 7
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.
up to 23 days
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.
Up to 23 days
Change From Baseline in Heart Rate (HR)
HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values
12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Up to 23 days
Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels
Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values
Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels
Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Hematocrit Level
Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Mean Corpuscle Volume (MCV) Levels
Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count
Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels
Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Up to 23 days
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)
Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).
At Day 2
Log Transformed AUC[0-60] of Acetaminophen
Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
At Day 2
Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)
Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
At Day 2
Log Transformed C60 of 3-OMG
Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
At Day 2
Derived Tmax of 3-OMG Post Intolerance
Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.
At Day 2
Percentage of Participants That Became Intolerant
Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.
Up to Day 7
Time to Development of Feeding Intolerance
Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.
Up to Day 7
GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Day 2
GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Baseline, Day 2, Day 3, Day 4
GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Baseline, Day 2, Day 3, Day 4
GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Baseline, Day 2, Day 3, Day 4
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes
The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.
up to 23 days
Total GRV for 24 hr Period
Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.
Up to Day 7
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance
Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Day 2, Day 3, Day 4, Day 7
Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.
Day 2 and Day 4
Derived Tmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.
Day 2 and Day 4
Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.
Day 2 and Day 4
Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance
To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.
Baseline, Day 2, Day 3, Day 4
Augusta
Georgia
30909
United States
GSK Investigational Site
Louisville
Kentucky
40202
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19104
United States
GSK Investigational Site
Randwick
New South Wales
2031
Australia
GSK Investigational Site
Southport
Queensland
4215
Australia
GSK Investigational Site
Adelaide
South Australia
5000
Australia
GSK Investigational Site
Woodville
South Australia
5011
Australia
GSK Investigational Site
Calgary
Alberta
T1Y 6J4
Canada
GSK Investigational Site
Calgary
Alberta
T2N 2T9
Canada
GSK Investigational Site
Hamilton
Ontario
L8L 2X2
Canada
GSK Investigational Site
Kingston
Ontario
K7L 2V7
Canada
GSK Investigational Site
Ottawa
Ontario
K1H 8L6
Canada
GSK Investigational Site
Ottawa
Ontario
K1Y 4E9
Canada
GSK Investigational Site
Toronto
Ontario
M5G 1X5
Canada
GSK Investigational Site
Montreal
Quebec
H2X 3J4
Canada
GSK Investigational Site
Québec
Quebec
G1J 1Z4
Canada
GSK Investigational Site
Sainte-Foy
Quebec
G1V 4G5
Canada
GSK Investigational Site
Sherbrooke
Quebec
J1H 5N4
Canada
FG001
Baseline EN Tolerant: Camicinal/Metoclopramide
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
FG002
Baseline EN Intolerant: Camicinal
Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
FG003
Baseline EN Intolerant: Metoclopramide
Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
FG00040 subjects
FG00144 subjects
FG0024 subjects
FG0034 subjects
COMPLETED
FG00031 subjects
FG00137 subjects
FG0023 subjects
FG0033 subjects
NOT COMPLETED
FG0009 subjects
FG0017 subjects
FG0021 subjects
FG0031 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Other: reached stopping criteria
FG0006 subjects
FG0015 subjects
FG0021 subjects
FG0030 subjects
Physician Decision
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Baseline EN Tolerant: Placebo/Camicinal
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
BG001
Baseline EN Tolerant: Camicinal/Metoclopramide
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
BG002
Baseline EN Intolerant: Camicinal
Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
BG003
Baseline EN Intolerant: Metoclopramide
Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00144
BG0024
BG0034
BG00492
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00055.1± 15.93
BG00159.8± 16.64
BG00264.3± 13.40
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race, Customized
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.
Intension To Treat [ITT (exposed)] Population. ITT (exposed) Population comprised of all randomized participants who received at least of one dose of study treatment.
Posted
Mean
95% Confidence Interval
Percentage of goal volume
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
OG00042
OG00138
Title
Denominators
Categories
Title
Measurements
OG00076.6(67.0 to 86.3)
OG00167.7(57.6 to 77.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Final Values)
8.9
Standard Error of the Mean
7.02
2-Sided
95
-5.1
22.9
Superiority or Other
Primary
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Per Protocol (PP) Population. PP Population comprised of all randomized participants who receive at least two doses of study treatment and have at least two days of evaluable nutritional data and also comply with the protocol.
Posted
Mean
95% Confidence Interval
Percentage of goal volume
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Secondary
Average Percentage Goal Calories Delivered Prior to Development of Intolerance
The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
ITT (exposed) Population
Posted
Mean
95% Confidence Interval
Percentage of goal calories
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Secondary
Average Percentage Goal Protein Delivered Prior to Development of Intolerance
The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
ITT (exposed) Population
Posted
Mean
95% Confidence Interval
Percentage of goal protein
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Secondary
Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance
Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.
ITT (exposed) Population
Posted
Median
Inter-Quartile Range
Days
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.
Safety Population. Safety Population comprised of all participants who received at least one dose one study treatment.
Posted
Number
Participants
up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
millimeter of mercury (mmHg)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Secondary
Change From Baseline in Heart Rate (HR)
HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
beats per minute (bpm)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Secondary
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values
12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Safety Population.
Posted
Number
Participants
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
Secondary
Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Gram per liter (g/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Secondary
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels
Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
International Unit per liter (IU/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
Secondary
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
micromoles per Liter (µmol/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values
Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
millimol per liter (mmol/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Giga unit per liter (gI/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
Secondary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels
Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
g/L
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Secondary
Change From Baseline in Hematocrit Level
Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Fraction of 1
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Secondary
Change From Baseline in Mean Corpuscle Volume (MCV) Levels
Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Femtoliter (fL)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Secondary
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count
Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Tetra unit per liter (TI/L)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Secondary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels
Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.
Safety Population.
Posted
Mean
Standard Deviation
Picogram (PG)
Up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
OG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Secondary
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)
Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).
ITT (exposed) Population.
Posted
Geometric Mean
95% Confidence Interval
Log [nanogram per milliliter (ng/mL)]
At Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Secondary
Log Transformed AUC[0-60] of Acetaminophen
Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
ITT (exposed) Population.
Posted
Geometric Mean
95% Confidence Interval
Log [min into ng/mL (min*ng/mL)]
At Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Secondary
Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)
Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
ITT (exposed) Population.
Posted
Geometric Mean
95% Confidence Interval
Log [Min. into mmol/L (min*mmol/l)]
At Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Secondary
Log Transformed C60 of 3-OMG
Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
ITT (exposed) Population.
Posted
Geometric Mean
95% Confidence Interval
Log (mmol/L)
At Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
Secondary
Derived Tmax of 3-OMG Post Intolerance
Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.
PK Population. Data for Tmax was not collected.
Posted
At Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants That Became Intolerant
Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.
ITT (exposed) Population. Two participants in the camicinal group and one participant in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.
Posted
Number
Percentage of participants
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
Secondary
Time to Development of Feeding Intolerance
Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.
ITT (exposed) Population. Two subjects in the Camicinal group and one subject in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.
Posted
Mean
Standard Error
Hr
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.
Posted
Geometric Mean
95% Confidence Interval
min*ng/mL
Day 2
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Baseline, Day 2, Day 3, Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
Secondary
GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
95% Confidence Interval
min*mmol/l
Baseline, Day 2, Day 3, Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
Secondary
GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
ITT (exposed) Population. Only those participants available at the pre-dose visit were analyzed.
Posted
Geometric Mean
95% Confidence Interval
mmol/l
Baseline, Day 2, Day 3, Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes
The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.
Enrolled Population
Posted
Number
Participants
up to 23 days
ID
Title
Description
OG000
Baseline EN Tolerant: Placebo/Camicinal
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route.
OG001
Baseline EN Tolerant: Camicinal/Metoclopramide
Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route.
OG002
Baseline EN Intolerant: Camicinal
Secondary
Total GRV for 24 hr Period
Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.
ITT (exposed) Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
Posted
Mean
Standard Deviation
mL
Up to Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
OG001
Placebo
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Placebo drug once daily via NG tube.
Units
Counts
Participants
Secondary
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance
Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
PK Population.
Posted
Geometric Mean
95% Confidence Interval
Log (ng/mL)
Day 2, Day 3, Day 4, Day 7
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.
PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
Posted
Geometric Mean
95% Confidence Interval
Log (ng/mL)
Day 2 and Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Derived Tmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.
PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Posted
Median
Full Range
Hr
Day 2 and Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.
PK Population.
Posted
Geometric Mean
Standard Deviation
min*mmol/l
Day 2 and Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG000
Secondary
Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance
To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.
PK Population. data were not collected.
Posted
Baseline, Day 2, Day 3, Day 4
ID
Title
Description
OG000
Camicinal 50 mg
EN tolerant participants at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube.
Units
Counts
Participants
OG0000
Time Frame
Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose.
Description
AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Baseline EN Tolerant: Placebo
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment.
1
35
9
35
EG001
Baseline EN Tolerant: Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment.
4
39
13
39
EG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
0
3
2
3
EG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
0
3
2
3
EG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
0
4
0
4
EG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
2
4
3
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG004
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0013 affected39 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Gastric dilatation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Enterococcal infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0021 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram ST segment depression
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Liver function test increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Cheyne-Stokes respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0021 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected35 at risk
EG0013 affected39 at risk
EG0020 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Skin graft failure
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0012 affected39 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Device dislocation
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected39 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected39 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
AE
Title
Measurements
OG0009
OG00113
OG0022
OG0032
OG0040
OG0053
SAE
Title
Measurements
OG0001
OG0014
OG0020
OG003
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
DBP Day1; n= 23,33,1,3,0,0
Title
Measurements
OG000-1.1± 10.51
OG001-1.0± 9.84
OG0025.0± NANA indicates that data were not available.
OG003-2.0± 13.89
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
DBP Day2; n= 33,38,2,2,0,0
Title
Measurements
OG0002.7± 12.77
OG001-0.2± 11.66
OG002-1.5± NANA indicates that data were not available.
OG003
DBP Day3; n= 29,31,1,1,0,0
Title
Measurements
OG0002.2± 12.12
OG0011.7± 10.44
OG0025.0± NANA indicates that data were not available.
OG003
DBP Day4; n=25,27,0,0,0,0
Title
Measurements
OG0002.9± 15.03
OG0013.2± 13.37
OG002NA± NANA indicates that data were not available.
OG003
DBP Day5; n= 22,23,0,0,0,0
Title
Measurements
OG0005.3± 16.12
OG001-0.7± 15.66
OG002NA± NANA indicates that data were not available.
OG003
DBP Day6; n= 18,19,0,0,0,0
Title
Measurements
OG0002.6± 17.03
OG0012.3± 15.86
OG002NA± NANA indicates that data were not available.
OG003
DBP Day7; n= 14,14,0,0,0,0
Title
Measurements
OG000-4.6± 15.33
OG001-2.4± 13.89
OG002NA± NANA indicates that data were not available.
OG003
DBP Intolerance Day1; n=1,0,3,3,3,3
Title
Measurements
OG0007.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0029.3± 4.04
OG003
DBP Intolerance Day2; n=0,0,2,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.5± NANA indicates that data were not available.
OG003
DBP Intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00210.5± NANA indicates that data were not available.
OG003
DBP Intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0029.0± NANA indicates that data were not available.
OG003
DBP Intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-5.0± NANA indicates that data were not available.
OG003
DBP Intolerance Day6; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00214.5± NANA indicates that data were not available.
OG003
DBP Intolerance Day7; n= 0,0,0,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
DBP Follow up; n= 27,28,3,3,4,2
Title
Measurements
OG0009.1± 20.14
OG0016.7± 13.70
OG00223.0± 6.08
OG003
SBP Day1; n= 23,33,1,3,0,0
Title
Measurements
OG000-4.6± 19.58
OG0011.0± 24.37
OG0021.0± NANA indicates that data were not available.
OG003
SBP Day2; n= 33,38,2,2,0,0
Title
Measurements
OG0003.7± 22.66
OG0011.4± 23.55
OG00212.5± NANA indicates that data were not available.
OG003
SBP Day3; n= 29,31,1,1,0,0
Title
Measurements
OG0005.1± 28.06
OG0014.9± 25.00
OG0026.0± NANA indicates that data were not available.
OG003
SBP Day4; n= 25,27,0,0,0,0
Title
Measurements
OG0007.6± 21.76
OG0016.0± 30.02
OG002NA± NANA indicates that data were not available.
OG003
SBP Day5; n= 22,23,0,0,0,0
Title
Measurements
OG00011.3± 27.16
OG001-0.6± 34.31
OG002NA± NANA indicates that data were not available.
OG003
SBP Day6; n= 18,19,0,0,0,0
Title
Measurements
OG000-1.6± 34.29
OG001-4.2± 33.26
OG002NA± NANA indicates that data were not available.
OG003
SBP Day7; n= 14,14,0,0,0,0
Title
Measurements
OG000-2.5± 37.96
OG001-5.4± 24.47
OG002NA± NANA indicates that data were not available.
OG003
SBP Intolerance Day1; n= 1,0,3,3,3,3
Title
Measurements
OG000-2.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00216.3± 12.66
OG003
SBP Intolerance Day2; n= 0,0,2,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.5± NANA indicates that data were not available.
OG003
SBP Intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00211.0± NANA indicates that data were not available.
OG003
SBP Intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00219.5± NANA indicates that data were not available.
OG003
SBP Intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00217.0± NANA indicates that data were not available.
OG003
SBP Intolerance Day6; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00246.5± NANA indicates that data were not available.
OG003
SBP Intolerance Day7; n= 0,0,0,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
SBP follow up; n= 27,28,3,3,4,2
Title
Measurements
OG000-0.6± 25.75
OG001-1.4± 30.61
OG00226.0± 17.58
OG003
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
HR Day1; n= 23,33,1,3,0,0
Title
Measurements
OG000-4.0± 10.05
OG0014.3± 14.13
OG002-5.0± NANA indicates that data were not available.
OG003-0.7± 11.50
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
HR Day2; n= 34,38,2,2,0,0
Title
Measurements
OG000-1.6± 15.23
OG001-0.5± 14.61
OG0024.5± NANA indicates that data were not available.
OG003
HR Day3; n= 29,31, 1,1,0,0
Title
Measurements
OG000-0.0± 19.68
OG0011.6± 12.93
OG00226.0± NANA indicates that data were not available.
OG003
HR Day4; n= 25,27,0,0,0,0
Title
Measurements
OG000-4.4± 19.84
OG0012.1± 14.96
OG002NA± NANA indicates that data were not available.
OG003
HR Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-3.0± 19.21
OG0010.2± 17.17
OG002NA± NANA indicates that data were not available.
OG003
HR Day6; n= 18,19,0,0,0,0
Title
Measurements
OG000-1.2± 22.26
OG0011.4± 19.46
OG002NA± NANA indicates that data were not available.
OG003
HR Day7; n= 14,14,,0,0,0,0
Title
Measurements
OG000-1.9± 19.17
OG0010.6± 22.85
OG002NA± NANA indicates that data were not available.
OG003
HR intolerance Day1; n= 1,0,3,3,3,3
Title
Measurements
OG0006.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00219.7± 8.08
OG003
HR intolerance Day2; n= 0,0,2,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00222.5± NANA indicates that data were not available.
OG003
HR intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0028.5± NANA indicates that data were not available.
OG003
HR intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00215.5± NANA indicates that data were not available.
OG003
HR intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0029.0± NANA indicates that data were not available.
OG003
HR intolerance Day6; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.5± NANA indicates that data were not available.
OG003
HR intolerance Day7; n= 0,0,0,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
HR follow up; n= 27,28,3,3,4,2
Title
Measurements
OG0000.8± 19.76
OG0012.7± 25.05
OG00211.0± 15.87
OG003
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Day 1; QTc <= 60; n= 10,5,0,1,0,0
Title
Measurements
OG00010
OG0015
OG0020
OG0031
OG0040
OG0050
Day 1; QTc >60; n= 10,5,0,1,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 1; QTcB <=60; n= 23,28,3,2,0,0
Title
Measurements
OG00023
OG00127
OG0023
OG003
Day 1; QTcB >60; n= 23,28,3,2,0,0
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 1; QTcF <=60; n= 23,28,3,2,0,0
Title
Measurements
OG00023
OG00127
OG0023
OG003
Day 1; QTcF >60; n= 23,28,3,2,0,0
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 2; QTc <= 60; n= 8,7,0,1,0,0
Title
Measurements
OG0008
OG0017
OG0020
OG003
Day 2; QTc >60; n= 8,7,0,1,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 2; QTcB <=60; n= 23,28,2,1,0,0
Title
Measurements
OG00023
OG00126
OG0022
OG003
Day 2; QTcB >60; n= 23,28,2,1,0,0
Title
Measurements
OG0000
OG0012
OG0020
OG003
Day 2; QTcF <=60; n= 23,28,2,1,0,0
Title
Measurements
OG00023
OG00127
OG0022
OG003
Day 2; QTcF >60; n= 23,28,2,1,0,0
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 3; QTc <= 60; n= 7,6,0,1,0,0
Title
Measurements
OG0007
OG0016
OG0020
OG003
Day 3; QTc >60; n= 7,6,0,1,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 3; QTcB <=60; n= 19,21,1,0,0
Title
Measurements
OG00018
OG00121
OG0021
OG003
Day 3; QTcB >60; n= 19,21,1,0,0
Title
Measurements
OG0001
OG0010
OG0020
OG003
Day 3; QTcF; <=60; n= 19,21,1,0,0,0
Title
Measurements
OG00019
OG00121
OG0021
OG003
Day 3; QTcF; >60; n= 19,21,1,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 4; QTc; <=60; n= 7,5,0,0,0,0
Title
Measurements
OG0007
OG0015
OG0020
OG003
Day 4; QTc; >60; n= 7,5,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 4; QTcB; <=60; n= 16,19,0,0,0,0
Title
Measurements
OG00016
OG00119
OG0020
OG003
Day 4; QTcB; >60; n= 16,19,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 4; QTcF; <=60; n= 16,19,0,0,0,0
Title
Measurements
OG00016
OG00119
OG0020
OG003
Day 4; QTcF; >60; n= 16,19,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 5; QTc; <=60; n= 7,5,0,0,0,0
Title
Measurements
OG0007
OG0015
OG0020
OG003
Day 5; QTc; >60; n= 7,5,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 5; QTcB; <=60; n= 14,17,0,0,0,0
Title
Measurements
OG00014
OG00117
OG0020
OG003
Day 5; QTcB; >60; n= 14,17,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 5; QTcF; <=60; n= 14,17,0,0,0,0
Title
Measurements
OG00014
OG00116
OG0020
OG003
Day 5; QTcF; >60; n= 14,17,0,0,0,0
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 6; QTc; <=60; n= 5,5,0,0,0,0
Title
Measurements
OG0005
OG0015
OG0020
OG003
Day 6; QTc; >60; n= 5,5,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 6; QTcB; <=60; n= 11,14,0,0,0,0
Title
Measurements
OG00011
OG00114
OG0020
OG003
Day 6; QTcB; >60; n= 11,14,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 6; QTcF; <=60; n= 11,14,0,0,0,0
Title
Measurements
OG00011
OG00114
OG0020
OG003
Day 6; QTcF; >60; n= 11,14,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7; QTc; <=60; n= 5,4,0,0,0,0
Title
Measurements
OG0005
OG0014
OG0020
OG003
Day 7; QTc; >60; n= 5,4,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7; QTcB; <=60; n= 8,11,0,0,0,0
Title
Measurements
OG0008
OG00111
OG0020
OG003
Day 7; QTcB; >60; n= 8,11,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7; QTcF; <=60; n= 8,11,0,0,0,0
Title
Measurements
OG0008
OG00111
OG0020
OG003
Day 7; QTcF; >60; n= 8,11,0,0,0,0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Follow up; QTc; <=60; n= 6,4,0,1,1,1
Title
Measurements
OG0006
OG0014
OG0020
OG003
Follow up; QTc; >60; n= 6,4,0,1,1,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Follow up; QTcB; <=60; n= 10,13,2,2,3,1
Title
Measurements
OG0009
OG00113
OG0022
OG003
Follow up; QTcB; >60; n= 10,13,2,2,3,1
Title
Measurements
OG0001
OG0010
OG0020
OG003
Follow up; QTcF;<=60; n= 10,13,2,2,2,1
Title
Measurements
OG0009
OG00113
OG0022
OG003
Follow up; QTcF; >60; n= 10,13,2,2,2,1
Title
Measurements
OG0001
OG0010
OG0020
OG003
Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1
Title
Measurements
OG0000
OG0010
OG0023
OG003
Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1
Title
Measurements
OG0000
OG0010
OG0023
OG003
Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1
Title
Measurements
OG0000
OG0010
OG0023
OG003
Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1
Title
Measurements
OG0000
OG0010
OG0023
OG003
Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1
Title
Measurements
OG0000
OG0010
OG0021
OG003
Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1
Title
Measurements
OG0000
OG0010
OG0021
OG003
Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0022
OG003
Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Albumin Day 2; n=1,1,0,0,0,0
Title
Measurements
OG0004.00± NANA indicates that data were not available.
OG001-1.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003NA± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Albumin; Day 3; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-3.50± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin Day 4; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-3.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin Day 5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.50± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin Day 6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-4.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin Day 7; n= 13,11,0,0,0,0
Title
Measurements
OG0000.98± 6.202
OG0010.64± 6.795
OG002NA± NANA indicates that data were not available.
OG003
Albumin intolerance Day 2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin intolerance Day 3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin intolerance Day 4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Albumin intolerance Day 6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.00± NANA indicates that data were not available.
OG003
Albumin intolerance Day 7; n= 0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-6.00± NANA indicates that data were not available.
OG003
Albumin follow up; n= 18,17,3,3,4,2
Title
Measurements
OG0005.81± 5.827
OG0014.59± 6.526
OG0024.73± 5.139
OG003
Total protein Day 2; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-3.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein Day 3; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0019.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein Day 5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0017.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein Day 6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-2.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein Day 7; n= 10,11,0,0,0,0
Title
Measurements
OG00010.06± 9.663
OG0013.21± 4.733
OG002NA± NANA indicates that data were not available.
OG003
Total protein intolerance Day 2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein intolerance Day 3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein intolerance Day 4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Total protein intolerance Day 6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00222.00± NANA indicates that data were not available.
OG003
Total protein intolerance Day 7; n= 0,0,1,0,1,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.00± NANA indicates that data were not available.
OG003
Total protein follow up; n= 15,16,3,3,4,2
Title
Measurements
OG00016.27± 13.598
OG00116.43± 10.423
OG00220.77± 2.250
OG003
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Alk. phosp. Day 2; n= 32,34,2,2,0,0
Title
Measurements
OG0002.7± 19.60
OG0017.9± 19.39
OG0022.5± NANA indicates that data were not available.
OG003-2.5± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
ALk. phosp. Day 3; n= 28,28,1,1,0,0
Title
Measurements
OG000-1.5± 42.47
OG00121.5± 27.98
OG00243.0± NANA indicates that data were not available.
OG003
Alk. phosp. Day 4; n= 25,25,0,0,0,0
Title
Measurements
OG00011.2± 24.62
OG00125.4± 38.55
OG002NA± NANA indicates that data were not available.
OG003
Alk. phsp Day5; n= 22,23,0,0,0,0
Title
Measurements
OG00014.2± 33.14
OG00136.6± 49.26
OG002NA± NANA indicates that data were not available.
OG003
Alk. phsp Day6; n= 18,19,0,0,0,0
Title
Measurements
OG00013.4± 36.49
OG00153.6± 78.10
OG002NA± NANA indicates that data were not available.
OG003
Alk. phsp. Day7; n= 14,13,0,0,0,0
Title
Measurements
OG00013.9± 33.93
OG00174.6± 93.12
OG002NA± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG00024.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00238.0± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00237.7± 37.55
OG003
Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00222.0± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00247.0± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00246.5± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00251.5± NANA indicates that data were not available.
OG003
Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00276.0± NANA indicates that data were not available.
OG003
Alk.phosp. follow up; n= 17,20,3,2,4,2
Title
Measurements
OG00032.4± 85.80
OG00176.0± 147.05
OG002274.0± 272.24
OG003
ALT Day 2; n= 32,35,2,2,0,0
Title
Measurements
OG000-1.9± 16.07
OG0012.0± 16.53
OG002-19.5± NANA indicates that data were not available.
OG003
ALT Day 3; n= 29,30,1,1,0,0
Title
Measurements
OG000-2.8± 37.00
OG0017.2± 27.49
OG0026.0± NANA indicates that data were not available.
OG003
ALT Day 4; n= 25,25,0,0,0,0
Title
Measurements
OG000-4.0± 53.27
OG0017.0± 29.81
OG002NA± NANA indicates that data were not available.
OG003
ALT Day 5; n= 22,23,0,0,0,0
Title
Measurements
OG0000.4± 70.15
OG0016.7± 34.80
OG002NA± NANA indicates that data were not available.
OG003
ALT Day 6; n= 18,19,0,0,0,0
Title
Measurements
OG0000.1± 84.99
OG0018.5± 44.37
OG002NA± NANA indicates that data were not available.
OG003
ALT Day 7; n= 14,13,0,0,0,0
Title
Measurements
OG000-5.4± 95.92
OG00114.8± 75.08
OG002NA± NANA indicates that data were not available.
OG003
ALT intolerance Day 1; n= 1,0,2,3,0,0
Title
Measurements
OG0001.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-2.0± NANA indicates that data were not available.
OG003
ALT intolerance Day 2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-25.3± 38.37
OG003
ALT intolerance Day 3; n= n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-68.0± NANA indicates that data were not available.
OG003
ALT intolerance Day 4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-77.0± NANA indicates that data were not available.
OG003
ALT intolerance Day 5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-81.0± NANA indicates that data were not available.
OG003
ALT intolerance Day 6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-75.5± NANA indicates that data were not available.
OG003
ALT intolerance Day 7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-20.0± NANA indicates that data were not available.
OG003
ALT follow up; n= n= 18,20,3,3,4,2
Title
Measurements
OG000-4.6± 93.05
OG00129.2± 62.61
OG002-59.7± 68.73
OG003
AST Day 2; n= 31,34,2,1,0,0
Title
Measurements
OG000-8.742± 40.5873
OG0010.118± 23.3936
OG002-36.500± NANA indicates that data were not available.
OG003
AST Day3; n= 28,29,1,1,0,0
Title
Measurements
OG000-11.500± 65.8598
OG001-4.828± 39.6260
OG002-18.000± NANA indicates that data were not available.
OG003
AST Day4; n= 23,23,0,0,0,0
Title
Measurements
OG000-14.348± 83.2317
OG001-14.870± 60.7329
OG002NA± NANA indicates that data were not available.
OG003
AST Day5; n= 22,22,0,0,0,0
Title
Measurements
OG000-11.518± 88.6693
OG001-14.318± 66.3672
OG002NA± NANA indicates that data were not available.
OG003
AST Day6; n= 18,18,0,0,0,0
Title
Measurements
OG000-18.222± 99.4494
OG001-10.944± 75.4262
OG002NA± NANA indicates that data were not available.
OG003
AST Day7; n= 13,12,0,0,0,0
Title
Measurements
OG000-29.538± 115.0454
OG001-11.417± 104.7147
OG002NA± NANA indicates that data were not available.
OG003
AST intolerance Day1; n= 1,0,2,1,0,0
Title
Measurements
OG000-11.000± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-50.000± NANA indicates that data were not available.
OG003
AST intolerance Day2; n= 0,0,3,1,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-69.000± 19.0000
OG003
AST intolerance Day3; n= 0,0,2,2,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-96.000± NANA indicates that data were not available.
OG003
AST intolerance Day4; n= 0,0,1,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-66.000± NANA indicates that data were not available.
OG003
AST intolerance Day5; n= 0,0,1,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-63.000± NANA indicates that data were not available.
OG003
AST intolerance Day6; n= 0,0,1,1,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-46.000± NANA indicates that data were not available.
OG003
AST intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-64.000± NANA indicates that data were not available.
OG003
AST follow up; n= 17,20,3,2,4,2
Title
Measurements
OG000-33.412± 99.3511
OG0014.500± 82.3551
OG002-110.333± 24.7049
OG003
GGT Day2; n= 32,34,2,2,0,0
Title
Measurements
OG0007.4± 38.77
OG00119.3± 41.39
OG0025.5± NANA indicates that data were not available.
OG003
GGT Day3; n= 28,28,1,1,0,0
Title
Measurements
OG00013.4± 95.74
OG00149.8± 62.30
OG00275.0± NANA indicates that data were not available.
OG003
GGT Day4; n= 24,24,0,0,0,0
Title
Measurements
OG00054.8± 77.91
OG00151.0± 52.82
OG002NA± NANA indicates that data were not available.
OG003
GGT Day5; n= 22,22,0,0,0,0
Title
Measurements
OG00081.7± 106.54
OG00182.1± 83.82
OG002NA± NANA indicates that data were not available.
OG003
GGT Day6; n= 18,18,0,0,0,0
Title
Measurements
OG000100.1± 150.79
OG001100.3± 104.52
OG002NA± NANA indicates that data were not available.
OG003
GGT Day7; n= 14,12,0,0,0,0
Title
Measurements
OG00085.6± 99.69
OG001156.0± 156.59
OG002NA± NANA indicates that data were not available.
OG003
GGT intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG00043.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00266.0± NANA indicates that data were not available.
OG003
GGT intolerance Day2; n= 0,0,3,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00251.0± 34.18
OG003
GGT intolerance Day3; n= 0,0,2,3,2,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00246.5± NANA indicates that data were not available.
OG003
GGT intolerance Day4; n= 0,0,2,2,2,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002153.0± NANA indicates that data were not available.
OG003
GGT intolerance Day5; n= 0,0,2,1,2,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002201.5± NANA indicates that data were not available.
OG003
GGT intolerance Day6; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002249.5± NANA indicates that data were not available.
OG003
GGT intolerance Day7; n= 0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002400.0± NANA indicates that data were not available.
OG003
GGT follow up; n= 18,20,3,3,3,2
Title
Measurements
OG00084.6± 158.30
OG00184.9± 164.37
OG002140.0± 89.87
OG003
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Direct bilirubin; Day 2; n= 28,26,2,1,0,0
Title
Measurements
OG000-1.246± 3.7551
OG0010.088± 2.8035
OG0020.800± NANA indicates that data were not available.
OG0031.000± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Direct bilirubin Day3; n= 25,23,1,1,0,0
Title
Measurements
OG000-1.512± 3.8420
OG001-0.126± 3.2325
OG00225.300± NANA indicates that data were not available.
OG003
Direct bilirubin; Day4; n= 19,18,0,0,0,0
Title
Measurements
OG0000.700± 6.2765
OG0010.172± 1.3323
OG002NA± NANA indicates that data were not available.
OG003
Direct bilirubin; Day5; n= 17,15,0,0,0,0
Title
Measurements
OG0001.482± 10.6636
OG001-1.007± 4.7148
OG002NA± NANA indicates that data were not available.
OG003
Direct bilirubin; Day6; n= 13,12,0,0,0,0
Title
Measurements
OG0001.031± 9.5551
OG001-0.583± 2.5933
OG002NA± NANA indicates that data were not available.
OG003
Direct bilirubin; Day7; n= 10,7,0,0,0,0
Title
Measurements
OG0003.240± 16.6513
OG001-1.214± 4.9229
OG002NA± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0
Title
Measurements
OG0000.000± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.100± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.100± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.000± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.000± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.000± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.000± NANA indicates that data were not available.
OG003
Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.000± NANA indicates that data were not available.
OG003
Direct bilirubin; follow up; n= 13,15,2,2,2,2
Title
Measurements
OG000-1.969± 3.6992
OG001-1.507± 4.2699
OG0020.100± NANA indicates that data were not available.
OG003
Total bilirubin; Day2; n= 32,35,2,2,0,0
Title
Measurements
OG000-1.172± 4.4060
OG0010.326± 4.0836
OG002-1.350± NANA indicates that data were not available.
OG003
Total bilirubin; Day3; n= 29,30,1,1,0,0
Title
Measurements
OG000-1.038± 3.6544
OG001-0.660± 7.4569
OG00225.700± NANA indicates that data were not available.
OG003
Total bilirubin; Day4; n= 25,25,0,0,0,0
Title
Measurements
OG0000.496± 8.6799
OG001-0.840± 7.1559
OG002NA± NANA indicates that data were not available.
OG003
Total bilirubin; Day5; n=22,22,0,0,0,0
Title
Measurements
OG0001.168± 12.9402
OG001-1.055± 6.5842
OG002NA± NANA indicates that data were not available.
OG003
Total bilirubin; Day6; n= 18,19,0,0,0,0
Title
Measurements
OG0000.772± 11.3841
OG001-1.558± 7.2077
OG002NA± NANA indicates that data were not available.
OG003
Total bilirubin; Day7; n= 14,12,0,0,0,0
Title
Measurements
OG0002.964± 17.7740
OG001-3.133± 10.6133
OG002NA± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-1.000± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0026.700± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.100± 4.5310
OG003
Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.000± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.500± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.500± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.500± NANA indicates that data were not available.
OG003
Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.000± NANA indicates that data were not available.
OG003
Total bilirubin; follow up; n= 19,20,3,2,4,2
Title
Measurements
OG000-1.263± 4.8442
OG001-1.805± 8.3199
OG002-0.467± 8.2978
OG003
Creatinine; Day2; n= 33,37,2,2,0,0
Title
Measurements
OG000-2.1818± 9.34898
OG001-1.4281± 28.09838
OG002-13.5000± NANA indicates that data were not available.
OG003
Creatinine; Day3; n= 29,31,1,1,0,0
Title
Measurements
OG000-4.2724± 16.74713
OG001-5.0323± 22.15774
OG002-3.0000± NANA indicates that data were not available.
OG003
Creatinine; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-6.2400± 14.29534
OG001-3.6923± 32.58683
OG002NA± NANA indicates that data were not available.
OG003
Creatinine; Day5; n= 22,22,0,0,0,0
Title
Measurements
OG000-7.0909± 16.52389
OG0011.5909± 52.62053
OG002NA± NANA indicates that data were not available.
OG003
Creatinine; Day6; n= 18,19,0,0,0,0
Title
Measurements
OG000-7.5000± 21.34658
OG00119.7895± 83.59198
OG002NA± NANA indicates that data were not available.
OG003
Creatinine; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-7.5714± 26.46831
OG0016.4000± 78.29322
OG002NA± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-11.0000± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.5000± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.6667± 10.06645
OG003
Creatinine; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-5.5000± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.0000± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-23.0000± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-28.5000± NANA indicates that data were not available.
OG003
Creatinine; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-50.0000± NANA indicates that data were not available.
OG003
Creatinine; follow up; n= 25,28,3,3,4,2
Title
Measurements
OG000-5.8400± 20.46477
OG00111.6786± 103.9060
OG002-34.0000± 13.52775
OG003
Uric acid; Day3; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-70.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-20.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001282.00± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; Day7; 11,11,0,0,0,0
Title
Measurements
OG000-20.18± 108.547
OG001-15.36± 152.550
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; intolerance Day3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; intolerance Day6; n= 0,0,0,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Uric acid; intolerance Day7; n= 0,0,1,0,1,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-270.00± NANA indicates that data were not available.
OG003
Uric acid follow up; n= 15,14,2,3,3,2
Title
Measurements
OG00060.47± 96.092
OG00158.36± 144.871
OG002-25.50± NANA indicates that data were not available.
OG003
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Calcium; Day 2; n= 1,2,0,0,0,0
Title
Measurements
OG000-0.0500± NANA indicates that data were not available.
OG0010.0000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003NA± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Calcium; Day 3; n= 1,2,0,0,0,0
Title
Measurements
OG0000.0200± NANA indicates that data were not available.
OG0010.1300± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; Day 4; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.0800± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; Day 5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.1500± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; Day 6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.0100± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; Day 7; n= 12,12,0,0,0,0
Title
Measurements
OG0000.2208± 0.29222
OG0010.0733± 0.12390
OG002NA± NANA indicates that data were not available.
OG003
Calcium; intolerance Day 2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; intolerance Day 3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; intolerance Day 4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Calcium; intolerance Day 6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.3400± NANA indicates that data were not available.
OG003
Calcium; intolerance Day 7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.0700± NANA indicates that data were not available.
OG003
Calcium; follow up; n= 19,18,3,3,4,2
Title
Measurements
OG0000.2821± 0.19277
OG0010.2483± 0.24957
OG0020.2667± 0.02517
OG003
Chloride; Day 2; n= 33,37,2,2,0,0
Title
Measurements
OG000-1.2± 2.66
OG001-0.6± 3.38
OG002-2.0± NANA indicates that data were not available.
OG003
Chloride; Day3; n= 28,31,1,1,0,0
Title
Measurements
OG000-1.5± 3.38
OG001-1.3± 4.26
OG002-5.0± NANA indicates that data were not available.
OG003
Chloride; Day4 ; n= 25,26,0,0,0,0
Title
Measurements
OG000-2.3± 3.93
OG001-1.8± 5.86
OG002NA± NANA indicates that data were not available.
OG003
Chloride; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-3.4± 5.64
OG001-2.6± 6.93
OG002NA± NANA indicates that data were not available.
OG003
Chloride; Day 6; n= 18,19,0,0,0,0
Title
Measurements
OG000-4.1± 7.28
OG001-4.8± 7.52
OG002NA± NANA indicates that data were not available.
OG003
Chloride; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-4.3± 7.49
OG001-3.1± 7.14
OG002NA± NANA indicates that data were not available.
OG003
Chloride intolerance Day 1; n= 1,0,2,3,0,0
Title
Measurements
OG000-1.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-6.0± NANA indicates that data were not available.
OG003
Chloride intolerance Day 2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-5.3± 3.21
OG003
Chloride intolerance Day 3; n= 0,0,2,3,2,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-6.5± NANA indicates that data were not available.
OG003
Chloride intolerance Day 4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-5.0± NANA indicates that data were not available.
OG003
Chloride intolerance Day 5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.5± NANA indicates that data were not available.
OG003
Chloride intolerance Day 6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.0± NANA indicates that data were not available.
OG003
Chloride intolerance Day 7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.0± NANA indicates that data were not available.
OG003
Chloride follow up; n= 22,23,3,3,3,2
Title
Measurements
OG000-6.1± 6.71
OG001-4.6± 6.27
OG002-7.3± 5.51
OG003
Carbon dioxide; Day 2; n= 32,36,2,2,0,0
Title
Measurements
OG0003.31± 10.711
OG0010.21± 3.770
OG0022.50± NANA indicates that data were not available.
OG003
Carbon dioxide; Day 3; n= 27,31,1,1,0,0
Title
Measurements
OG0001.64± 2.274
OG0010.93± 6.406
OG0026.00± NANA indicates that data were not available.
OG003
Carbon dioxide; Day 4; n= 24,25,0,0,0,0
Title
Measurements
OG0000.43± 3.958
OG0011.58± 8.054
OG002NA± NANA indicates that data were not available.
OG003
Carbon dioxide; Day 5; n= 20,22,0,0,0,0
Title
Measurements
OG000-0.16± 3.797
OG0011.64± 7.631
OG002NA± NANA indicates that data were not available.
OG003
Carbon dioxide; Day 6; n= 16,16,0,0,0,0
Title
Measurements
OG0000.64± 5.728
OG0013.63± 5.308
OG002NA± NANA indicates that data were not available.
OG003
Carbon dioxide; Day 7; n= 12,13,0,0,0,0
Title
Measurements
OG0000.98± 5.774
OG0013.05± 4.945
OG002NA± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG0002.00± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.50± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.67± 1.528
OG003
Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0026.50± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.50± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0026.50± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.50± NANA indicates that data were not available.
OG003
Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.00± NANA indicates that data were not available.
OG003
Carbon dioxide; follow up; n= 15,20,3,3,3,2
Title
Measurements
OG000-1.26± 6.069
OG001-0.40± 5.088
OG0021.67± 2.082
OG003
Glucose; Day2; n= 31,35,2,2,0,0
Title
Measurements
OG0000.2871± 2.68325
OG001-0.2338± 1.89890
OG002-0.8000± NANA indicates that data were not available.
OG003
Glucose; Day3; n= 29,29,1,1,0,0
Title
Measurements
OG0000.2414± 3.12667
OG0010.0655± 2.10514
OG002-2.9000± NANA indicates that data were not available.
OG003
Glucose; Day4; n= 25,24,0,0,0,0
Title
Measurements
OG0000.7680± 2.69764
OG001-0.1458± 1.96778
OG002NA± NANA indicates that data were not available.
OG003
Glucose; Day5; n= 22,21,0,0,0,0
Title
Measurements
OG0000.4636± 2.76811
OG0010.1810± 2.05928
OG002NA± NANA indicates that data were not available.
OG003
Glucose; Day6; n= 18,18,0,0,0,0
Title
Measurements
OG0000.8111± 3.37445
OG0010.0889± 1.74150
OG002NA± NANA indicates that data were not available.
OG003
Glucose; Day7; n= 14,13,0,0,0,0
Title
Measurements
OG0001.8857± 4.17702
OG0010.8692± 2.33323
OG002NA± NANA indicates that data were not available.
OG003
Glucose; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-0.9000± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.6000± NANA indicates that data were not available.
OG003
Glucose; intolerance Day2; n= 0,0,3,3,4,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.5000± 2.85132
OG003
Glucose; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.5000± NANA indicates that data were not available.
OG003
Glucose; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.8500± NANA indicates that data were not available.
OG003
Glucose; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.5500± NANA indicates that data were not available.
OG003
Glucose; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.1000± NANA indicates that data were not available.
OG003
Glucose; intolerance Day7; n= 0,0,1,0,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.8000± NANA indicates that data were not available.
OG003
Glucose; follow up; n= 18,17,3,3,4,2
Title
Measurements
OG000-0.8889± 2.55225
OG001-1.7176± 1.99663
OG002-1.9667± 3.21921
OG003
Potassium; Day2; n= 33,37,2,2,0,0
Title
Measurements
OG000-0.08± 0.474
OG0010.02± 0.447
OG002-0.20± NANA indicates that data were not available.
OG003
Potassium; Day3; n= 29,31,1,1,0,0
Title
Measurements
OG000-0.12± 0.582
OG0010.01± 0.489
OG002-0.40± NANA indicates that data were not available.
OG003
Potassium; DAY4; n= 24,25,0,0,0,0
Title
Measurements
OG0000.08± 0.705
OG0010.06± 0.515
OG002NA± NANA indicates that data were not available.
OG003
Potassium Day5; n= 22,23,0,0,0,0
Title
Measurements
OG0000.10± 0.559
OG0010.07± 0.644
OG002NA± NANA indicates that data were not available.
OG003
Potassium; Day6; n= 18,19,0,0,0,0
Title
Measurements
OG0000.33± 0.428
OG0010.09± 0.732
OG002NA± NANA indicates that data were not available.
OG003
Potassium; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG0000.49± 0.350
OG0010.05± 0.741
OG002NA± NANA indicates that data were not available.
OG003
Potassium; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG0000.40± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.00± NANA indicates that data were not available.
OG003
Potassium; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.00± 0.557
OG003
Potassium; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.30± NANA indicates that data were not available.
OG003
Potassium; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.15± NANA indicates that data were not available.
OG003
Potassium; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.35± NANA indicates that data were not available.
OG003
Potassium; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.05± NANA indicates that data were not available.
OG003
Potassium; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.10± NANA indicates that data were not available.
OG003
Potassium; follow up; n= 25,28,3,3,4,2
Title
Measurements
OG0000.37± 0.471
OG0010.11± 0.676
OG002-0.07± 0.379
OG003
Sodium; Day2; n= 33,37,2,2,0,0
Title
Measurements
OG0000.3± 2.02
OG0010.8± 3.34
OG0021.5± NANA indicates that data were not available.
OG003
Sodium; Day3; n= 29,31,1,1,0,0
Title
Measurements
OG0000.4± 2.47
OG0011.2± 4.20
OG0020.0± NANA indicates that data were not available.
OG003
Sodium; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-0.8± 4.03
OG0011.5± 4.92
OG002NA± NANA indicates that data were not available.
OG003
Sodium; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-1.4± 4.62
OG0010.8± 5.24
OG002NA± NANA indicates that data were not available.
OG003
Sodium; Day6; n= 18,19,0,0,0,0
Title
Measurements
OG000-2.8± 6.18
OG001-0.2± 6.39
OG002NA± NANA indicates that data were not available.
OG003
Sodium; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-2.7± 6.40
OG0010.1± 4.24
OG002NA± NANA indicates that data were not available.
OG003
Sodium; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-3.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.5± NANA indicates that data were not available.
OG003
Sodium; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.0± 2.65
OG003
Sodium; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.5± NANA indicates that data were not available.
OG003
Sodium; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0022.0± NANA indicates that data were not available.
OG003
Sodium; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.0± NANA indicates that data were not available.
OG003
Sodium; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.5± NANA indicates that data were not available.
OG003
Sodium; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0022.0± NANA indicates that data were not available.
OG003
Sodium; follow up; n= 25,28,3,3,4,2
Title
Measurements
OG000-3.8± 4.92
OG001-2.5± 5.12
OG002-3.0± 3.46
OG003
BUN; Day2; n= 1,3,0,0,0,0
Title
Measurements
OG0001.0000± NANA indicates that data were not available.
OG0012.3000± 4.60326
OG002NA± NANA indicates that data were not available.
OG003
BUN; Day3; n= 1,2,0,0,0,0
Title
Measurements
OG0006.4000± NANA indicates that data were not available.
OG0012.4000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; Day4; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0011.5000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG00125.8500± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG00129.2000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; Day7; n= 13,14,0,0,0,0
Title
Measurements
OG0003.1231± 5.15948
OG0015.0143± 9.35002
OG002NA± NANA indicates that data were not available.
OG003
BUN; intolerance Day3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
BUN; intolerance Day6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0027.4000± NANA indicates that data were not available.
OG003
BUN; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.0000± NANA indicates that data were not available.
OG003
BUN; follow up; n= 18,22,3,3,4,1
Title
Measurements
OG0002.1722± 5.48397
OG0011.7000± 6.75891
OG002-0.3333± 3.30807
OG003
OG002
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Basophils; Day2; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003NA± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Basophils; Day3; n= 2,1,0,0,0,0
Title
Measurements
OG0000.000± NANA indicates that data were not available.
OG001-0.020± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Basophils; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.050± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Basophils; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Basophils; Day7; n= 13,14,0,0,0,0
Title
Measurements
OG0000.022± 0.0402
OG0010.013± 0.0281
OG002NA± NANA indicates that data were not available.
OG003
Basophils; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NAc
OG003
Basophils; intolerance Day3; n= 0,0,0,2,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Basophils; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Basophils; intolerance Day6; n= 0,0,1,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.000± NANA indicates that data were not available.
OG003
Basophils; intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.130± NANA indicates that data were not available.
OG003
Basophils; follow up; n= 24,28,3,3,3,1
Title
Measurements
OG0000.040± 0.0546
OG0010.034± 0.0619
OG0020.047± 0.0503
OG003
Eosinophils; Day2; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.0000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; Day3; n= 2,1,0,0,0,0
Title
Measurements
OG0000.3000± NANA indicates that data were not available.
OG001-0.0400± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.0900± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.2000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; Day7; n= 13,14,0,0,0,0
Title
Measurements
OG0000.1615± 0.12877
OG0010.1079± 0.22337
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; intolerance Day3; n= 0,0,0,2,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Eosinophils; intolerance Day6; n= 0,0,1,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.0000± NANA indicates that data were not available.
OG003
Eosinophils; intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.7900± NANA indicates that data were not available.
OG003
Eosinophils; follow up; n= 24,28,3,3,4,1
Title
Measurements
OG0001.4454± 6.27749
OG0010.1886± 0.27639
OG0020.3367± 0.14844
OG003
Lymphocytes; Day2; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.2000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; Day3; n= 2,1,0,0,0,0
Title
Measurements
OG0000.6500± NANA indicates that data were not available.
OG001-1.0300± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.4400± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.2000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; Day7; n= 13,15,0,0,0,0
Title
Measurements
OG0000.3946± 0.56592
OG0010.2320± 0.66890
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.1000± NANA indicates that data were not available.
OG003
Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.4600± NANA indicates that data were not available.
OG003
Lymphocytes; follow up; n= 24,28,3,3,4,2
Title
Measurements
OG0000.6483± 0.51967
OG0010.6614± 0.75393
OG0020.3133± 0.53529
OG003
Monocytes; Day2; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.4000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; Day3; n= 2,1,0,0,0,0
Title
Measurements
OG0000.5000± NANA indicates that data were not available.
OG001-0.0600± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.0300± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.2000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; Day7; n= 13,15,0,0,0,0
Title
Measurements
OG0000.2100± 0.59020
OG0010.1647± 0.49461
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; intolerance Day3; n= 0,0,0,2,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Monocytes; intolerance Day6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.9000± NANA indicates that data were not available.
OG003
Monocytes; intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.6900± NANA indicates that data were not available.
OG003
Monocytes; follow up; n= 24,28,3,3,3,1
Title
Measurements
OG0000.1475± 0.55989
OG0010.0611± 0.39000
OG002-0.1067± 0.46058
OG003
Neutrophils; Day2; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-1.5000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; Day3; n= 2,1,0,0,0,0
Title
Measurements
OG000-5.3000± NANA indicates that data were not available.
OG0010.7200± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; Day5; n= 0,2,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.3750± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0019.6000± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; Day7; n= 13,15,0,0,0,0
Title
Measurements
OG0000.6708± 7.11859
OG0011.1807± 3.99306
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; intolerance Day2; n= 0,0,0,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; intolerance Day3; n= 0,0,0,2,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Neutrophils; intolerance Day6; n= 0,0,1,1,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.1000± NANA indicates that data were not available.
OG003
Neutrophils; intolerance Day7; n= 0,0,1,0,3,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.4600± NANA indicates that data were not available.
OG003
Neutrophils; follow up; n= 24,28,3,3,4,2
Title
Measurements
OG000-2.0579± 6.73610
OG001-2.0968± 3.26061
OG002-0.7133± 5.15272
OG003
Platelet; Day2; n= 32,37,2,2,0,0
Title
Measurements
OG00010.5± 40.92
OG0014.2± 22.00
OG0028.5± NANA indicates that data were not available.
OG003
Platelet; Day3; n= 29,30,1,1,0,0
Title
Measurements
OG00034.8± 65.68
OG00122.1± 35.90
OG002-4.0± NANA indicates that data were not available.
OG003
Platelet; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG00056.0± 98.65
OG00148.7± 55.92
OG002NA± NANA indicates that data were not available.
OG003
Platelet; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000102.7± 141.00
OG00182.7± 75.37
OG002NA± NANA indicates that data were not available.
OG003
Platelet; Day6; n= 17,19,0,0,0,0
Title
Measurements
OG000128.7± 168.94
OG001113.6± 95.44
OG002NA± NANA indicates that data were not available.
OG003
Platelet; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000159.8± 229.46
OG001133.3± 99.92
OG002NA± NANA indicates that data were not available.
OG003
Platelet; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-24.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00233.5± NANA indicates that data were not available.
OG003
Platelet; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG00273.7± 21.20
OG003
Platelet; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002101.5± NANA indicates that data were not available.
OG003
Platelet; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002183.0± NANA indicates that data were not available.
OG003
Platelet; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002213.5± NANA indicates that data were not available.
OG003
Platelet; intolerance day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002225.5± NANA indicates that data were not available.
OG003
Platelet; intolerance day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002287.0± NANA indicates that data were not available.
OG003
Platelet; follow up; n= 24,28,3,3,4,2
Title
Measurements
OG000258.9± 268.60
OG001272.0± 226.86
OG002438.0± 194.76
OG003
WBC; Day2; n= 32,37,2,2,0,0
Title
Measurements
OG000-1.187± 3.5946
OG001-0.199± 2.5427
OG002-2.490± NANA indicates that data were not available.
OG003
WBC; Day3; n= 29,30,1,1,0,0
Title
Measurements
OG000-1.033± 5.8272
OG0010.398± 3.0461
OG0020.300± NANA indicates that data were not available.
OG003
WBC; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-1.398± 6.0244
OG0010.489± 3.7565
OG002NA± NANA indicates that data were not available.
OG003
WBC; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-0.015± 6.5214
OG0011.320± 3.6270
OG002NA± NANA indicates that data were not available.
OG003
WBC; Day6; n= 17,19,0,0,0,0
Title
Measurements
OG0000.881± 8.4975
OG0012.314± 4.6829
OG002NA± NANA indicates that data were not available.
OG003
WBC; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG0000.690± 8.9417
OG0011.913± 3.8002
OG002NA± NANA indicates that data were not available.
OG003
WBC; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-2.020± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.300± NANA indicates that data were not available.
OG003
WBC; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.197± 2.1019
OG003
WBC; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-1.910± NANA indicates that data were not available.
OG003
WBC; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.150± NANA indicates that data were not available.
OG003
WBC; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.850± NANA indicates that data were not available.
OG003
WBC; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.750± NANA indicates that data were not available.
OG003
WBC; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0024.000± NANA indicates that data were not available.
OG003
WBC; follow up; n= 24,28,3,3,4,2
Title
Measurements
OG000-1.223± 7.5546
OG001-0.813± 3.7488
OG002-0.177± 5.0906
OG003
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Hemoglobin; Day2; n= 32,37,2,2,0,0
Title
Measurements
OG000-2.7± 8.13
OG001-1.8± 6.62
OG002-10.5± NANA indicates that data were not available.
OG003-4.5± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Hemoglobin; Day3; n= 29,30,1,1,0,0
Title
Measurements
OG000-4.6± 8.91
OG001-2.1± 8.67
OG002-6.0± NANA indicates that data were not available.
OG003
Hemoglobin; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-4.8± 7.71
OG001-4.7± 7.59
OG002NA± NANA indicates that data were not available.
OG003
Hemoglobin; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-3.2± 10.40
OG001-3.6± 10.28
OG002NA± NANA indicates that data were not available.
OG003
Hemoglobin; Day6; n= 17,19,0,0,0,0
Title
Measurements
OG000-5.6± 14.04
OG001-4.7± 10.19
OG002NA± NANA indicates that data were not available.
OG003
Hemoglobin; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-5.9± 14.22
OG001-5.9± 11.06
OG002NA± NANA indicates that data were not available.
OG003
Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-16.0± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0022.0± NANA indicates that data were not available.
OG003
Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-4.7± 3.06
OG003
Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-11.5± NANA indicates that data were not available
OG003
Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-5.0± NANA indicates that data were not available
OG003
Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-13.0± NANA indicates that data were not available
OG003
Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-14.0± NANA indicates that data were not available
OG003
Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-13.0± NANA indicates that data were not available
OG003
Hemoglobin; follow up; n= 24,28,3,3,4,2
Title
Measurements
OG0005.1± 19.13
OG0014.3± 13.21
OG00215.7± 9.87
OG003
MCHC; Day2; n= 31,37,2,2,0,0
Title
Measurements
OG000-1.26± 7.066
OG001-0.27± 5.966
OG002-2.50± NANA indicates that data were not available
OG003
MCHC; Day3; n= 28,30,1,1,0,0
Title
Measurements
OG000-1.29± 7.403
OG001-2.00± 7.339
OG002-13.00± NANA indicates that data were not available
OG003
MCHC; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-1.24± 8.232
OG001-5.54± 8.994
OG002NA± NANA indicates that data were not available
OG003
MCHC; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-16.50± 68.162
OG001-6.39± 9.852
OG002NA± NANA indicates that data were not available
OG003
MCHC; Day6; n= 17,19,0,0,0,0
Title
Measurements
OG000-1.94± 10.413
OG001-6.89± 11.110
OG002NA± NANA indicates that data were not available
OG003
MCHC; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-4.43± 13.461
OG001-4.40± 9.934
OG002NA± NANA indicates that data were not available
OG003
MCHC; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG0000.00± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-18.50± NANA indicates that data were not available
OG003
MCHC; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-19.00± 23.065
OG003
MCHC; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-6.00± NANA indicates that data were not available
OG003
MCHC; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-12.50± NANA indicates that data were not available
OG003
MCHC; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-6.50± NANA indicates that data were not available
OG003
MCHC; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-13.00± NANA indicates that data were not available
OG003
MCHC; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available
OG001NA± NANA indicates that data were not available
OG002-25.00± NANA indicates that data were not available
OG003
MCHC; follow up; n= 23,27,3,3,4,4
Title
Measurements
OG000-2.57± 10.135
OG001-6.33± 14.475
OG002-22.00± 29.138
OG003
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Day2; n= 32,37,2,2,0,0
Title
Measurements
OG000-0.0072± 0.02369
OG001-0.0048± 0.02013
OG002-0.0310± NANA indicates that the data was not available
OG003-0.0195± NANA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
Day3; n= 29,30,1,1,0,0
Title
Measurements
OG000-0.0129± 0.02555
OG001-0.0046± 0.02342
OG002-0.0090± NANA indicates that the data was not available
OG003
Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-0.0140± 0.02358
OG001-0.0107± 0.02226
OG002NA± NANA indicates that the data was not available
OG003
Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-0.0085± 0.02886
OG001-0.0064± 0.02956
OG002NA± NANA indicates that the data was not available
OG003
Day6; n= 17,19,0,0,0,0
Title
Measurements
OG000-0.0152± 0.03950
OG001-0.0088± 0.03036
OG002NA± NANA indicates that the data was not available
OG003
Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-0.0148± 0.04008
OG001-0.0145± 0.03551
OG002NA± NANA indicates that the data was not available
OG003
Intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-0.0400± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG0020.0195± NANA indicates that the data was not available
OG003
Intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0017± 0.02438
OG003
Intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0310± NANA indicates that the data was not available
OG003
Intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0050± NANA indicates that the data was not available
OG003
Intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0350± NANA indicates that the data was not available
OG003
Intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0320± NANA indicates that the data was not available
OG003
Intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that the data was not available
OG001NA± NANA indicates that the data was not available
OG002-0.0200± NANA indicates that the data was not available
OG003
Follow up; n= 24,28,3,3,4,2
Title
Measurements
OG0000.0183± 0.05406
OG0010.0179± 0.04098
OG0020.0650± 0.05679
OG003
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Day2; n= 31,37,2,2,0,0
Title
Measurements
OG0000.36± 1.349
OG0010.14± 1.478
OG0021.70± NANA indicates that data were not available.
OG003-0.50± NANA indicates that data were not available.
OG004-0.60± 0.876
OG005NA± NANA indicates that data were not available.
Day3; n= 28,30,1,1,0,0
Title
Measurements
OG0000.13± 1.431
OG0010.40± 1.627
OG0023.90± NANA indicates that data were not available.
OG003
Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-0.14± 2.108
OG0010.79± 2.017
OG002NA± NANA indicates that data were not available.
OG003
Day5; n= 22,23,0,0,0,0
Title
Measurements
OG0000.09± 2.661
OG0010.40± 2.042
OG002NA± NANA indicates that data were not available
OG003
Day6; n= 17,19,0,0,0,0
Title
Measurements
OG0000.17± 3.098
OG0010.53± 2.515
OG002NA± NANA indicates that data were not available.
OG003
Day7; n= 14,15,0,0,0,0
Title
Measurements
OG0001.04± 3.680
OG001-0.01± 2.669
OG002NA± NANA indicates that data were not available.
OG003
Intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG0000.50± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.10± NANA indicates that data were not available.
OG003
Intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.43± 3.182
OG003
Intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0021.30± NANA indicates that data were not available.
OG003
Intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.05± NANA indicates that data were not available.
OG003
Intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0022.90± NANA indicates that data were not available.
OG003
Intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0023.95± NANA indicates that data were not available.
OG003
Intolerance Day7; n= 0,01,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0025.10± NANA indicates that data were not available.
OG003
Follow up; n= 23,27,3,3,4,2
Title
Measurements
OG000-0.24± 3.394
OG0011.46± 4.280
OG0024.57± 3.774
OG003
Baseline EN Tolerant: Placebo/Camicinal 50 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
RBC; Day2; n= 32,37,2,2,0,0
Title
Measurements
OG000-0.098± 0.2816
OG001-0.059± 0.2262
OG002-0.375± NANA indicates that data were not available.
OG003-0.150± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
RBC; Day3; n= 29,30,1,1,0,0
Title
Measurements
OG000-0.163± 0.3001
OG001-0.067± 0.2776
OG002-0.210± NANA indicates that data were not available.
OG003
RBC; Day4; n= 25,26,0,0,0,0
Title
Measurements
OG000-0.155± 0.3038
OG001-0.141± 0.2417
OG002NA± NANA indicates that data were not available.
OG003
RBC; Day5; n= 22,23,0,0,0,0
Title
Measurements
OG000-0.099± 0.3676
OG001-0.085± 0.3246
OG002NA± NANA indicates that data were not available.
OG003
RBC; Day6; n= 17,19,0,0,0,0
Title
Measurements
OG000-0.176± 0.4999
OG001-0.118± 0.3403
OG002NA± NANA indicates that data were not available.
OG003
RBC; Day7; n= 14,15,0,0,0,0
Title
Measurements
OG000-0.202± 0.4849
OG001-0.149± 0.3610
OG002NA± NANA indicates that data were not available.
OG003
RBC; intolerance Day1; n= 1,0,2,3,0,0
Title
Measurements
OG000-0.540± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.120± NANA indicates that data were not available.
OG003
RBC; intolerance Day2; n= 0,0,3,3,4,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.113± 0.1701
OG003
RBC; intolerance Day3; n= 0,0,2,3,3,4
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.390± NANA indicates that data were not available.
OG003
RBC; intolerance Day4; n= 0,0,2,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.165± NANA indicates that data were not available.
OG003
RBC; intolerance Day5; n= 0,0,2,1,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.495± NANA indicates that data were not available.
OG003
RBC; intolerance Day6; n= 0,0,2,1,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.505± NANA indicates that data were not available.
OG003
RBC; intolerance Day7; n= 0,0,1,0,3,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.400± NANA indicates that data were not available.
OG003
RBC follow up; n= 24,28,3,3,4,2
Title
Measurements
OG0000.195± 0.6553
OG0010.142± 0.4196
OG0020.577± 0.4826
OG003
Reticulocytes; Day5; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001-0.0010± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; Day6; n= 0,1,0,0,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG0010.0810± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; Day7; n= 7,4,0,0,0,0
Title
Measurements
OG0000.0074± 0.04599
OG0010.0031± 0.01158
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002NA± NANA indicates that data were not available.
OG003
Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.0170± NANA indicates that data were not available.
OG003
Reticulocytes; follow up; n= 11,11,2,2,3,2
Title
Measurements
OG0004.1273± 13.55607
OG0011.6622± 5.41884
OG0020.0847± NANA indicates that data were not available.
OG003
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily.
OG003
Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg
Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route.
OG004
Baseline EN Intolerant: Camicinal 50 mg
Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube.
OG005
Baseline EN Intolerant: Metoclopramide 10 mg
Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route.
Units
Counts
Participants
OG00035
OG00139
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Day2; n= 27,35,2,1,0,0
Title
Measurements
OG0000.01± 0.522
OG0010.02± 0.531
OG0020.35± NANA indicates that data were not available.
OG0030.00± NANA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
Day3; n= 24,28,1,0,0,0
Title
Measurements
OG000-0.10± 0.581
OG001-0.08± 0.547
OG0020.20± NANA indicates that data were not available.
OG003
Day4; n= 21,24,0,0,0,0
Title
Measurements
OG000-0.26± 0.685
OG001-0.24± 0.690
OG002NA± NANA indicates that data were not available.
OG003
Day5; n= 19,21,0,0,0,0
Title
Measurements
OG000-0.23± 0.628
OG001-0.44± 0.494
OG002NA± NANA indicates that data were not available.
OG003
Day6; n= 15,17,0,0,0,0
Title
Measurements
OG000-0.15± 0.505
OG001-0.41± 0.431
OG002NA± NANA indicates that data were not available.
OG003
Day7; n= 12,14,0,0,0,0
Title
Measurements
OG000-0.02± 0.488
OG001-0.45± 0.435
OG002NA± NANA indicates that data were not available.
OG003
Intolerance Day1; n= 1,0,2,2,0,0
Title
Measurements
OG0000.20± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.65± NANA indicates that data were not available.
OG003
Intolerance Day2; n= 0,0,3,2,3,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.57± 1.060
OG003
Intolerance Day3; n= 0,0,2,2,2,3
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.10± NANA indicates that data were not available.
OG003
Intolerance Day4; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.10± NANA indicates that data were not available.
OG003
Intolerance Day5; n= 0,0,2,1,2,2
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.45± NANA indicates that data were not available.
OG003
Intolerance Day6; n= 0,0,2,1,2,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG0020.20± NANA indicates that data were not available.
OG003
Intolerance Day7; n= 0,0,1,0,2,1
Title
Measurements
OG000NA± NANA indicates that data were not available.
OG001NA± NANA indicates that data were not available.
OG002-0.50± NANA indicates that data were not available.
OG003
Follow up; n= 21,26,3,2,3,2
Title
Measurements
OG000-0.40± 0.889
OG001-0.20± 0.944
OG002-0.50± 1.652
OG003
Units
Counts
Participants
OG00042
OG00138
Title
Denominators
Categories
C60; Pre-dose; n= 42,36
Title
Measurements
OG0004108.99(3357.46 to 5028.74)
OG0014374.35(3157.08 to 6060.97)
C60; post-dose; n= 33,27
Title
Measurements
OG0004504.30(3428.13 to 5918.29)
OG0014691.64(3917.56 to 5618.66)
Cmax; pre-dose; n= 42,36
Title
Measurements
OG0005482.09(4529.01 to 6635.72)
OG0016068.34(4428.15 to 8316.07)
Cmax; post-dose; n= 33,27
Title
Measurements
OG0006576.47(5123.54 to 8441.42)
OG0016319.73(5251.08 to 7605.87)
Participants
OG00042
OG00138
Title
Denominators
Categories
Pre-dose; n=42,36
Title
Measurements
OG000192321.7(153049.5 to 241671.0)
OG001222411.3(161086.4 to 307082.4)
Post-dose; n= 33,27
Title
Measurements
OG000234538.9(174645.6 to 314972.3)
OG001228473.7(185338.9 to 281647.5)
Participants
OG00042
OG00138
Title
Denominators
Categories
Pre-dose; n=38,34
Title
Measurements
OG0003.3709(2.2283 to 5.0993)
OG0013.8341(2.5286 to 5.8136)
Post-dose; n= 32,27
Title
Measurements
OG0007.2872(5.9044 to 8.9938)
OG0016.1047(4.3137 to 8.6394)
OG00042
OG00138
Title
Denominators
Categories
C60; Pre-dose
Title
Measurements
OG0000.12547(0.09174 to 0.17159)
OG0010.12856(0.09001 to 0.18362)
C60; post-dose
Title
Measurements
OG0000.19960(0.15935 to 0.25000)
OG0010.18723(0.13985 to 0.25065)
0
OG00040
OG00137
Title
Denominators
Categories
Title
Measurements
OG00015
OG00114
40
OG00137
Title
Denominators
Categories
Title
Measurements
OG000102.9± 5.39
OG001108.0± 6.26
42
OG00136
Title
Denominators
Categories
Title
Measurements
OG000192321.7(153049.5 to 241671.0)
OG001222411.3(161086.4 to 307082.4)
OG000
42
OG00136
Title
Denominators
Categories
Title
Measurements
OG0005482.09(4529.01 to 6635.72)
OG0016068.34(4428.15 to 8316.07)
OG00038
OG00134
Title
Denominators
Categories
AUC(0-60); n= 38, 34
Title
Measurements
OG0003.3709(2.2283 to 5.0993)
OG0013.8341(2.5286 to 5.8136)
AUC(0-240); n= 36, 33
Title
Measurements
OG00031.4065(23.7921 to 41.4578)
OG00126.4060(17.8925 to 38.9703)
38
OG00134
Title
Denominators
Categories
Title
Measurements
OG0000.12547(0.09174 to 0.17159)
OG0010.12856(0.09001 to 0.18362)
Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route.
OG003
No Treatment
Participant who did not receive treatment.
Units
Counts
Participants
OG00040
OG00144
OG0024
OG0034
Title
Denominators
Categories
Vomiting
Title
Measurements
OG0006
OG0017
OG0020
OG0031
Macroaspiration
Title
Measurements
OG0000
OG0011
OG0021
OG003
Regurgitation
Title
Measurements
OG0001
OG0011
OG0020
OG003
OG000
42
OG00138
Title
Denominators
Categories
Day 1; n= 36,34
Title
Measurements
OG00037.2± 64.64
OG00192.7± 184.83
Day 2; n= 34,32
Title
Measurements
OG000118.5± 290.26
OG001191.6± 259.93
Day 3; n= 29,26
Title
Measurements
OG000169.7± 259.73
OG001143.3± 258.46
Day 4; n= 23,22
Title
Measurements
OG000131.9± 178.71
OG00183.3± 106.55
Day 5; n= 19,19
Title
Measurements
OG000185.2± 312.93
OG00197.5± 150.45
Day 6; n= 15,15
Title
Measurements
OG000180.0± 313.03
OG001135.7± 285.43
Day 7; n= 12,10
Title
Measurements
OG00085.6± 155.67
OG00160.2± 45.66
42
Title
Denominators
Categories
Day 2; n= 25
Title
Measurements
OG000952.55(740.67 to 1225.04)
Day 3; n=3
Title
Measurements
OG000748.28(87.38 to 6408.21)
Day 4; n= 5
Title
Measurements
OG0001722.74(1167.35 to 2542.38)
Day 7; n= 5
Title
Measurements
OG0001206.67(753.77 to 1931.70)
7
Title
Denominators
Categories
Intolerance Day 2; n= 2
Title
Measurements
OG000168.56(NA to NA)NA indicates that the data were not available.
Intolerance Day 4; n= 1
Title
Measurements
OG000704.40(NA to NA)NA indicates that the data were not available.
7
Title
Denominators
Categories
Intolerance Day 2; n= 2
Title
Measurements
OG0002.717(1.93 to 3.50)
Intolerance day 4; n= 1
Title
Measurements
OG0001.500(1.50 to 1.50)
1
Title
Denominators
Categories
Intolerance Day 2
Title
Measurements
OG000792.8± NASD was not provided if n\<3
Intolerance Day 4
Title
Measurements
OG0002698.8± NASD was not provided if n\<3
0 affected
4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
2 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
0
OG0040
OG0052
6.5
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-16.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.3
± 11.27
OG00411.0± 7.81
OG0050.0± 14.42
-12.0
± 6.24
OG00423.5± 17.71
OG005-4.0± 15.08
6.3
± 9.07
OG0044.3± 8.39
OG005-0.5± 4.36
15.5
± NA
NA indicates that data were not available.
OG00411.7± 8.50
OG005-1.7± 9.24
2.0
± NA
NA indicates that data were not available.
OG0045.3± 4.51
OG0051.7± 18.50
-3.0
± NA
NA indicates that data were not available.
OG0047.3± 4.62
OG00513.7± 25.97
NA
± NA
NA indicates that data were not available.
OG0047.7± 7.51
OG0058.5± NANA indicates that data were not available.
18.0
± 4.58
OG0044.0± 6.98
OG00529.0± NANA indicates that data were not available.
3.0
± 23.64
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
16.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-16.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
1.7
± 11.50
OG0041.0± 13.08
OG005-4.7± 9.07
-9.3
± 10.60
OG00432.8± 31.06
OG005-4.0± 7.79
16.3
± 22.37
OG00430.7± 12.22
OG00513.0± 21.18
22.0
± NA
NA indicates that data were not available.
OG00443.0± 16.52
OG005-9.0± 12.29
15.0
± NA
NA indicates that data were not available.
OG00419.7± 24.79
OG0058.7± 7.02
5.0
± NA
NA indicates that data were not available.
OG00420.3± 21.73
OG00510.7± 10.41
NA
± NA
NA indicates that data were not available.
OG00422.0± 11.36
OG00513.0± NANA indicates that data were not available.
3.0
± 28.51
OG00411.8± 18.14
OG00514.0± NANA indicates that data were not available.
5.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-21.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-2.0
± 13.89
OG0041.3± 13.61
OG0052.3± 2.52
-12.7
± 16.62
OG0049.0± 17.47
OG0057.5± 11.90
0.7
± 12.50
OG0046.3± 11.93
OG00513.5± 12.48
-2.0
± NA
NA indicates that data were not available.
OG00414.0± 19.47
OG0055.3± 3.21
-3.0
± NA
NA indicates that data were not available.
OG00419.0± 29.87
OG00517.3± 16.17
-1.0
± NA
NA indicates that data were not available.
OG00419.7± 22.85
OG00517.0± 11.53
NA
± NA
NA indicates that data were not available.
OG00416.3± 20.50
OG00516.0± NANA indicates that data were not available.
-2.0
± 19.08
OG00416.8± 21.73
OG00527.0± NANA indicates that data were not available.
0
OG0040
OG0050
2
OG0040
OG0050
0
OG0040
OG0050
2
OG0040
OG0050
0
OG0040
OG0050
1
OG0040
OG0050
0
OG0040
OG0050
1
OG0040
OG0050
0
OG0040
OG0050
1
OG0040
OG0050
0
OG0040
OG0050
1
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
1
OG0041
OG0051
0
OG0040
OG0050
2
OG0043
OG0051
0
OG0040
OG0050
2
OG0042
OG0051
0
OG0040
OG0050
1
OG0041
OG0052
0
OG0040
OG0050
2
OG0043
OG0051
0
OG0040
OG0050
2
OG0043
OG0051
0
OG0040
OG0050
1
OG0041
OG0052
0
OG0040
OG0050
2
OG0042
OG0051
0
OG0040
OG0050
2
OG0042
OG0051
0
OG0040
OG0050
1
OG0041
OG0053
0
OG0040
OG0050
2
OG0042
OG0051
0
OG0040
OG0050
2
OG0042
OG0051
0
OG0040
OG0050
1
OG0041
OG0052
0
OG0040
OG0050
1
OG0042
OG0051
0
OG0040
OG0050
1
OG0042
OG0051
0
OG0040
OG0050
0
OG0041
OG0051
0
OG0040
OG0051
1
OG0042
OG0051
0
OG0040
OG0050
1
OG0042
OG0051
0
OG0040
OG0050
0
OG0041
OG0052
0
OG0040
OG0050
1
OG0042
OG0051
0
OG0040
OG0050
1
OG0042
OG0051
0
OG0040
OG0050
0
OG0041
OG0051
0
OG0040
OG0050
0
OG0042
OG0051
0
OG0040
OG0050
0
OG0042
OG0051
0
OG0040
OG0050
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0057.00± NANA indicates that data were not available.
-3.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
7.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-3.00
± NA
NA indicates that data were not available.
OG00411.00± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.00± NANA indicates that data were not available.
OG0051.20± NANA indicates that data were not available.
8.33
± 3.512
OG0045.25± 4.500
OG0052.30± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0057.00± NANA indicates that data were not available.
6.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
14.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
8.00
± NA
NA indicates that data were not available.
OG0042.00± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0042.00± NANA indicates that data were not available.
OG00510.75± NANA indicates that data were not available.
22.33
± 7.234
OG0044.50± 17.540
OG00518.60± NANA indicates that data were not available.
19.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
11.7
± 14.19
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
20.0
± 10.44
OG0045.8± 13.10
OG00518.0± 35.13
23.0
± 17.69
OG004-5.0± 21.07
OG00539.3± 38.34
56.5
± NA
NA indicates that data were not available.
OG0042.3± 23.07
OG00556.0± 45.13
67.0
± NA
NA indicates that data were not available.
OG00435.5± NANA indicates that data were not available.
OG00581.3± 16.56
56.0
± NA
NA indicates that data were not available.
OG00429.7± 46.82
OG00553.5± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG00425.0± 47.16
OG00565.5± NANA indicates that data were not available.
71.5
± NA
NA indicates that data were not available.
OG00477.5± 86.03
OG005110.5± NANA indicates that data were not available.
-1.5
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
8.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
9.3
± 15.50
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
14.0
± 7.55
OG0046.5± 9.47
OG00528.3± 61.24
14.3
± 9.61
OG0048.3± 10.50
OG00534.5± 55.70
41.5
± NA
NA indicates that data were not available.
OG00424.3± 30.09
OG005118.3± 65.55
50.0
± NA
NA indicates that data were not available.
OG00434.0± 47.66
OG005193.7± 59.58
45.0
± NA
NA indicates that data were not available.
OG00444.3± 57.87
OG005189.0± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG00435.3± 49.17
OG005136.5± NANA indicates that data were not available.
50.7
± 62.74
OG00458.8± 56.20
OG00529.5± NANA indicates that data were not available.
-9.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
16.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
1.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
28.000
± NA
NA indicates that data were not available.
OG0048.500± 15.1548
OG0056.000± 8.0829
22.000
± NA
NA indicates that data were not available.
OG0040.333± 2.0817
OG00520.250± 16.8795
49.500
± NA
NA indicates that data were not available.
OG00422.000± 32.1870
OG005126.333± 91.1939
46.000
± NA
NA indicates that data were not available.
OG00419.000± 27.0555
OG005281.000± NANA indicates that data were not available.
30.000
± NA
NA indicates that data were not available.
OG00418.667± 17.4738
OG005374.000± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.333± 10.0167
OG005171.000± NANA indicates that data were not available.
8.500
± NA
NA indicates that data were not available.
OG00447.000± 81.5475
OG005-3.500± NANA indicates that data were not available.
8.5
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
74.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
41.7
± 52.37
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
59.0
± 47.57
OG00421.0± 11.79
OG00525.3± 41.42
89.0
± 73.08
OG00428.5± NANA indicates that data were not available.
OG00565.5± 86.38
216.0
± NA
NA indicates that data were not available.
OG00445.5± NANA indicates that data were not available.
OG005196.7± 129.53
223.0
± NA
NA indicates that data were not available.
OG00482.5± NANA indicates that data were not available.
OG005269.3± 60.07
218.0
± NA
NA indicates that data were not available.
OG004116.5± NANA indicates that data were not available.
OG005399.5± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004118.5± NANA indicates that data were not available.
OG005590.0± NANA indicates that data were not available.
78.0
± 29.87
OG004224.0± 24.56
OG005216.0± NANA indicates that data were not available.
0.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
1.000
± NA
NA indicates that data were not available.
OG0040.000± NANA indicates that data were not available.
OG0051.700± NANA indicates that data were not available.
0.500
± NA
NA indicates that data were not available.
OG0040.000± NANA indicates that data were not available.
OG00512.167± 19.9144
0.000
± NA
NA indicates that data were not available.
OG0040.500± NANA indicates that data were not available.
OG0054.800± NANA indicates that data were not available.
0.000
± NA
NA indicates that data were not available.
OG0040.000± NANA indicates that data were not available.
OG005-1.050± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.500± NANA indicates that data were not available.
OG005-7.100± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.500± NANA indicates that data were not available.
OG005-8.050± NANA indicates that data were not available.
-0.500
± NA
NA indicates that data were not available.
OG00416.000± NANA indicates that data were not available.
OG005-15.000± NANA indicates that data were not available.
0.500
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
1.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.667
± 2.5166
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
1.000
± 2.6458
OG004-0.075± 1.0751
OG0054.675± 6.6249
0.333
± 3.2146
OG0040.167± 0.7638
OG00510.475± 19.6274
3.000
± NA
NA indicates that data were not available.
OG0040.833± 2.7538
OG0053.333± 4.9329
0.000
± NA
NA indicates that data were not available.
OG0040.633± 2.0984
OG005-1.100± 4.2579
-1.000
± NA
NA indicates that data were not available.
OG0040.000± 2.0000
OG005-8.050± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.800± 2.3065
OG005-9.250± NANA indicates that data were not available.
-2.000
± NA
NA indicates that data were not available.
OG00410.850± 25.5152
OG005-17.000± NANA indicates that data were not available.
-5.0000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-3.0000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-1.6667
± 3.51188
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-5.6667
± 5.13160
OG0045.7500± 20.79062
OG005-1.5000± 11.90238
-4.6667
± 5.50757
OG0043.3333± 36.29509
OG005-21.5000± 22.60531
-6.0000
± NA
NA indicates that data were not available.
OG004-13.0000± 30.34798
OG005-14.0000± 22.60531
-10.0000
± NA
NA indicates that data were not available.
OG004-11.3333± 27.15388
OG005-16.6667± 20.59935
-10.0000
± NA
NA indicates that data were not available.
OG004-12.3333± 34.93327
OG005-32.5000± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-4.3333± 48.33563
OG005-34.0000± NANA indicates that data were not available.
-4.0000
± 11.35782
OG004-12.0000± 24.17988
OG005-39.0000± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005-3640.00± NANA indicates that data were not available.
-20.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
153.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-20.00
± NA
NA indicates that data were not available.
OG00427.00± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-100.00± NANA indicates that data were not available.
OG00560.40± NANA indicates that data were not available.
115.67
± 106.228
OG00472.33± 118.095
OG0051076.90± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005-0.0400± NANA indicates that data were not available.
0.3400
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.2100
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.3600
± NA
NA indicates that data were not available.
OG0040.4300± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.2000± 0.36661
OG0050.0200± NANA indicates that data were not available.
0.4767
± 0.22008
OG0040.2850± 0.39467
OG0050.2050± NANA indicates that data were not available.
-0.5
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-7.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-3.7
± 9.07
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-4.3
± 8.50
OG0040.5± 1.00
OG005-0.5± 3.42
-6.0
± 9.54
OG0040.0± NANA indicates that data were not available.
OG005-2.3± 4.99
-11.0
± NA
NA indicates that data were not available.
OG0042.3± 0.58
OG005-4.0± 7.00
-2.0
± NA
NA indicates that data were not available.
OG0044.3± 1.53
OG005-4.7± 4.51
-4.0
± NA
NA indicates that data were not available.
OG0045.7± 2.08
OG005-4.0± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0044.3± 4.04
OG005-6.5± NANA indicates that data were not available.
-11.0
± 5.57
OG004-7.0± 6.08
OG005-8.5± NANA indicates that data were not available.
1.50
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
3.00
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.33
± 2.082
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.33
± 0.577
OG004-2.00± 3.000
OG0050.93± 2.844
1.67
± 2.309
OG0041.00± NANA indicates that data were not available.
OG0052.80± 5.071
2.50
± NA
NA indicates that data were not available.
OG0042.00± NANA indicates that data were not available.
OG0054.40± NANA indicates that data were not available.
4.00
± NA
NA indicates that data were not available.
OG0043.00± NANA indicates that data were not available.
OG0054.75± NANA indicates that data were not available.
5.00
± NA
NA indicates that data were not available.
OG0042.00± NANA indicates that data were not available.
OG0054.15± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0043.00± NANA indicates that data were not available.
OG0052.65± NANA indicates that data were not available.
1.67
± 3.215
OG0041.67± 1.528
OG0051.45± NANA indicates that data were not available.
0.3000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-1.6000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.2000
± 1.30000
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.3000
± 0.62450
OG004-0.4500± 2.49600
OG0050.8000± 1.50000
0.1000
± 1.21244
OG0040.7333± 1.90875
OG0050.6000± 1.78699
-0.3000
± NA
NA indicates that data were not available.
OG0042.1000± 2.88444
OG0051.1667± 0.32146
0.2000
± NA
NA indicates that data were not available.
OG0041.2333± 3.27159
OG0050.9333± 0.87369
-0.7000
± NA
NA indicates that data were not available.
OG0040.8000± 1.70880
OG0050.6500± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0042.5000± NANA indicates that data were not available.
OG0050.1500± NANA indicates that data were not available.
-0.3333
± 0.72342
OG004-1.1750± 2.57083
OG0052.6000± NANA indicates that data were not available.
-0.20
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.10
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.17
± 0.379
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.17
± 0.289
OG0040.40± 0.258
OG005-0.18± 0.263
0.30
± 0.656
OG0040.30± 0.721
OG005-0.53± 1.011
0.45
± NA
NA indicates that data were not available.
OG0040.63± 0.945
OG005-0.10± 1.136
0.20
± NA
NA indicates that data were not available.
OG0040.67± 0.987
OG005-0.03± 1.115
0.40
± NA
NA indicates that data were not available.
OG0040.83± 1.115
OG005-0.55± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.87± 1.328
OG005-0.60± NANA indicates that data were not available.
0.47
± 0.651
OG0040.38± 0.443
OG005-0.10± NANA indicates that data were not available.
-0.5
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-5.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-2.3
± 6.66
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-3.3
± 6.66
OG004-0.5± 2.38
OG0051.0± 2.16
-3.0
± 8.89
OG0043.7± 3.21
OG005-0.5± 4.65
-8.0
± NA
NA indicates that data were not available.
OG0043.7± 2.31
OG0050.0± 6.93
1.0
± NA
NA indicates that data were not available.
OG0046.3± 2.31
OG0050.0± 6.08
-2.0
± NA
NA indicates that data were not available.
OG0047.3± 2.52
OG005-1.0± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0046.3± 6.66
OG005-2.5± NANA indicates that data were not available.
-7.0
± 6.08
OG004-0.5± 5.45
OG005-6.5± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.2000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.3000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
2.2000
± NA
NA indicates that data were not available.
OG00414.2000± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG00416.4000± 18.72004
OG0051.1500± NANA indicates that data were not available.
4.5667
± 1.59478
OG00411.6500± 21.03656
OG0052.8000± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005-0.030± NANA indicates that data were not available.
0.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.020
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.037± 0.0603
OG0050.300± NANA indicates that data were not available.
0.057
± 0.0379
OG0040.073± 0.1401
OG0050.150± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005-0.0200± NANA indicates that data were not available.
0.0300
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.0000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.3300
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.0000± 0.19079
OG0050.1000± NANA indicates that data were not available.
0.2267
± 0.14189
OG0040.0400± 0.81404
OG005-0.0200± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005-0.7300± NANA indicates that data were not available.
-0.3550
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.2000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.4800
± NA
NA indicates that data were not available.
OG0040.4000± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.1900± 0.19925
OG0051.5000± NANA indicates that data were not available.
0.7067
± 0.50013
OG0040.7100± 0.58395
OG005-0.1200± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0050.0600± NANA indicates that data were not available.
0.0900
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.1000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.3600
± NA
NA indicates that data were not available.
OG0040.5000± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.0600± 0.29866
OG0051.3000± NANA indicates that data were not available.
-0.0633
± 0.20502
OG004-0.4900± 0.56427
OG0050.3600± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0050.3100± NANA indicates that data were not available.
-2.1000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-2.9000
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.8100
± NA
NA indicates that data were not available.
OG0047.5000± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-1.7200± 8.10489
OG005-6.6000± NANA indicates that data were not available.
-0.5233
± 1.90500
OG0040.8250± 12.60760
OG005-6.7400± NANA indicates that data were not available.
14.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
10.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
21.0
± 39.89
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
13.7
± 73.15
OG004-8.8± 24.25
OG00516.3± 30.10
31.7
± 64.79
OG0040.7± 46.70
OG00529.0± 56.94
42.5
± NA
NA indicates that data were not available.
OG00411.0± 67.58
OG00586.3± 57.36
-10.0
± NA
NA indicates that data were not available.
OG00414.7± 75.24
OG005158.0± 99.05
42.0
± NA
NA indicates that data were not available.
OG00426.0± 84.55
OG005271.0± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG00449.7± 106.59
OG005429.0± NANA indicates that data were not available.
272.0
± 27.87
OG00466.8± 272.20
OG005891.0± NANA indicates that data were not available.
-2.320
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-4.400
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-1.220
± 2.6018
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-1.713
± 3.4082
OG004-1.050± 3.3491
OG0050.450± 4.6177
-1.447
± 2.4791
OG004-2.333± 5.1733
OG005-2.925± 4.9304
-2.125
± NA
NA indicates that data were not available.
OG004-1.300± 4.8446
OG005-2.933± 6.4733
-0.490
± NA
NA indicates that data were not available.
OG004-1.450± 8.5339
OG005-1.800± 5.4009
0.300
± NA
NA indicates that data were not available.
OG004-0.367± 8.8047
OG005-5.600± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.540± 8.7199
OG005-3.650± NANA indicates that data were not available.
0.230
± 2.4557
OG0042.188± 13.4717
OG005-6.150± NANA indicates that data were not available.
-7.0
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-4.0
± 1.73
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-8.7
± 7.57
OG0040.5± 4.20
OG005-4.5± 2.52
-11.0
± 4.58
OG004-2.7± 7.09
OG005-3.8± 4.27
-10.0
± NA
NA indicates that data were not available
OG004-0.7± 8.74
OG005-1.7± 5.69
-6.0
± NA
NA indicates that data were not available
OG004-7.0± 10.00
OG0054.3± 1.53
-7.0
± NA
NA indicates that data were not available
OG0045.7± 10.02
OG005-5.5± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG0042.7± 9.24
OG005-5.5± NANA indicates that data were not available
19.0
± 8.19
OG0043.5± 8.81
OG0052.5± NANA indicates that data were not available
3.00
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
6.00
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
1.00
± 8.544
OG004NA± NANA indicates that data were not available
OG005NA± NANA indicates that data were not available
1.67
± 12.702
OG004-0.50± 4.655
OG005-3.00± 6.831
5.33
± 9.609
OG004-2.67± 9.815
OG005-3.75± 11.325
2.00
± NA
NA indicates that data were not available
OG004-4.00± 6.557
OG005-11.67± 18.230
-5.00
± NA
NA indicates that data were not available
OG004-10.00± 12.288
OG005-11.67± 23.352
-10.00
± NA
NA indicates that data were not available
OG004-8.00± 18.248
OG005-23.50± NANA indicates that data were not available
NA
± NA
NA indicates that data were not available
OG004-8.67± 15.535
OG005-8.50± NANA indicates that data were not available
-5.33
± 9.609
OG004-11.75± 11.026
OG005-25.00± NANA indicates that data were not available
-0.0300
± NA
NA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
NA
± NA
NA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
NA
± NA
NA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
NA
± NA
NA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
NA
± NA
NA indicates that the data was not available
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
-0.0150
± 0.00500
OG004NA± NANA indicates that the data was not available
OG005NA± NANA indicates that the data was not available
-0.0287
± 0.02203
OG004-0.1385± 0.26790
OG005-0.0113± 0.00699
-0.0373
± 0.02053
OG004-0.1917± 0.30168
OG005-0.0065± 0.00790
-0.0350
± NA
NA indicates that the data was not available
OG004-0.1803± 0.29416
OG0050.0030± 0.01836
-0.0200
± NA
NA indicates that the data was not available
OG004-0.1963± 0.29767
OG0050.0213± 0.01474
-0.0200
± NA
NA indicates that the data was not available
OG004-0.1617± 0.30168
OG005-0.0030± NANA indicates that the data was not available
NA
± NA
NA indicates that the data was not available
OG004-0.1673± 0.31439
OG005-0.0120± NANA indicates that the data was not available
0.0607
± 0.01793
OG004-0.1180± 0.26962
OG0050.0320± NANA indicates that the data was not available
0.00
± NA
NA indicates that data were not available.
OG004-2.47± 3.101
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-2.53± 2.194
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-1.10± 3.804
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-2.20± 5.800
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-1.13± 5.244
OG005NA± NANA indicates that data were not available.
-1.10
± 0.854
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.00
± 1.732
OG004NA± NANA indicates that data were not available.
OG0050.92± 1.187
-1.20
± 1.709
OG004NA± NANA indicates that data were not available.
OG0050.27± 2.968
-1.10
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0052.30± 4.107
0.10
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0053.13± 5.169
-0.20
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0055.60± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0054.15± NANA indicates that data were not available.
-2.93
± 0.902
OG004-0.77± 5.557
OG0054.00± NANA indicates that data were not available.
-0.200
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.077
± 0.0586
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.293
± 0.2335
OG0040.018± 0.1228
OG005-0.172± 0.1159
-0.333
± 0.1563
OG004-0.030± 0.2042
OG005-0.105± 0.1511
-0.270
± NA
NA indicates that data were not available.
OG0040.047± 0.3075
OG005-0.050± 0.2390
-0.150
± NA
NA indicates that data were not available.
OG004-0.157± 0.3371
OG0050.133± 0.0306
-0.130
± NA
NA indicates that data were not available.
OG0040.267± 0.3055
OG005-0.170± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.150± 0.2598
OG005-0.250± NANA indicates that data were not available.
0.790
± 0.1493
OG0040.188± 0.3636
OG0050.170± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.0530
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
0.0080
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG0040.0340± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG0050.0822± NANA indicates that data were not available.
0.0537
± NA
NA indicates that data were not available.
OG0040.0870± 0.02364
OG0050.0569± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.30
± NA
NA indicates that data were not available.
OG004NA± NANA indicates that data were not available.
OG005NA± NANA indicates that data were not available.
-0.10
± NA
NA indicates that data were not available.
OG004-0.23± 0.681
OG005-0.10± 0.265
-0.10
± NA
NA indicates that data were not available.
OG004-0.65± NANA indicates that data were not available.
OG005-0.27± 0.153
-0.60
± NA
NA indicates that data were not available.
OG004-0.75± NANA indicates that data were not available.
OG005-0.50± NANA indicates that data were not available.
-0.50
± NA
NA indicates that data were not available.
OG004-1.00± NANA indicates that data were not available.
OG005-0.30± NANA indicates that data were not available.
-1.10
± NA
NA indicates that data were not available.
OG004-1.00± NANA indicates that data were not available.
OG005-0.70± NANA indicates that data were not available.
NA
± NA
NA indicates that data were not available.
OG004-0.75± NANA indicates that data were not available.
OG0050.40± NANA indicates that data were not available.
-2.15
± NA
NA indicates that data were not available.
OG004-0.50± 0.800
OG005-0.90± NANA indicates that data were not available.