| Primary | Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12 | The number of HDDs is defined as the number of days per month [days/month] with alcohol consumption of > 60 g for males and > 40 g for females | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | days/month | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-12.25± 0.64
- OG001-12.09± 0.74
- OG002-7.91± 0.61
|
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| | 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 |
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| | Mixed Models Analysis | | 0.0001 | Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose. | Mean Difference (Final Values) | -4.34 | Standard Error of the Mean | 0.87 | 2-Sided | 95 | -6.05 | -2.62 | | | | | Superiority or Other (legacy) | Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. |
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| Secondary | Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24 | | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | days/month | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in Total Alcohol Consumption (TAC) From Baseline at Week 12 | | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | g/day | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
| |
| Secondary | Change in Total Alcohol Consumption (TAC) From Baseline at Week 24 | | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | g/day | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Response Shift Drinking Risk Level (RSDRL) at Week 12 | Proportion of patients with a downward shift in drinking risk level of two categories or more | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Response Shift Drinking Risk Level (RSDRL) at Week 24 | Proportion of patients with a downward shift in drinking risk level of two categories or more | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
| |
| Secondary | Response Low Drinking Risk Level (RLDRL) at Week 12 | Proportion of patients with low or lower drinking risk level | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
| |
| Secondary | Response Low Drinking Risk Level (RLDRL) at Week 24 | Proportion of patients with low or lower drinking risk level | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | 70% TAC Responder Rate at Week 12 | Proportion of patients with a 70% decrease in TAC | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | 70% TAC Responder Rate at Week 24 | Proportion of patients with a 70% decrease in TAC | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | HDD Responder Rate at Week 12 | Proportion of patients with ≤4 HDDs | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | HDD Responder Rate at Week 24 | Proportion of patients with ≤4 HDDs | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Number | | percentage | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in CGI-S From Baseline at Week 12 | The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in CGI-S From Baseline at Week 24 | The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in CGI-I From Baseline at Week 12 | The CGI-I scale is used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse). | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
| |
| Secondary | Change in CGI-I From Baseline at Week 24 | The CGI-I scale was used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse). | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12 | All-patients-randomised set | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | IU/L | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24 | All-patients-randomised set | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | IU/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12 | All-patients-randomised set | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | IU/L | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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| Secondary | Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24 | All-patients-randomised set | Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug. | Posted | | Least Squares Mean | Standard Error | IU/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nalmefene Hydrochloride 20 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG001 | Nalmefene Hydrochloride 10 mg | Nalmefene hydrochloride: As-needed; tablets, orally | | OG002 | Placebo | Placebo: As-needed; tablets, orally |
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