| Primary | Mean Change From Baseline to Month 12 for Hemoglobin Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.29± 0.873
- OG001-0.05± 0.959
|
|
| | 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 |
|---|
| | ANOVA | | 0.042 | Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance. | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Primary | Mean Change From Baseline to Month 12 for Hematocrit Values | Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference. | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | percentage | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 1 for PAGI-QOL Total Score | Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 3 for PAGI-QOL Total Score | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Red Blood Cell Count Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | Red Blood Cell count x10 to the 6/μL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Platelet Count Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | Platelet Count x10 to the 3/mcL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for White Blood Cell Count Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | White Blood Cell count x10 to the 3/mcL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Creatinine Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Calcium Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Total Bilirubin Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Serum Gastrin Levels | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Systolic Blood Pressure | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Diastolic Blood Pressure | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Mean Change From Baseline to Month 12 for Pulse Rate | | All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 6 for PAGI-QOL Total Score | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 9 for PAGI-QOL Total Score | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 12 for PAGI-QOL Total Score | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 1 for PAGI-SYM Total Score | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 3 for PAGI-SYM Total Score | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 6 for PAGI-SYM Total Score | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 9 for PAGI-SYM Total Score | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Secondary | Mean Change From Baseline to Month 12 for PAGI-SYM Total Score | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). | All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Changes From Baseline to Final Visit in Antrum Biopsy Results | Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. | All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing. | Posted | | Number | | subjects | | Baseline and Final Visit (up to 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |
| Primary | Changes From Baseline to Final Visit in Fundus Biopsy Results | Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. | All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing. | Posted | | Number | | subjects | | Baseline and Final Visit (up to 12 months) | | | | ID | Title | Description |
|---|
| OG000 | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | | OG001 | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months |
| |