| Primary | Number of Participants With Peripheral Edema | Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema). | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
| | | Title | Denominators | Categories |
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| Trace at Baseline (n=103) | | | | Pitting +1 at Baseline (n=103) | | | | Pitting +2 at Baseline (n=103) | | |
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| Primary | Number of Participants With Facial/Periorbital Edema | Number of participants who had facial or periorbital edema. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Generalized or Abdominal Edema | Number of participants who had generalized or abdominal edema. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 4, 20, 36, 52, and 53 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Visual Field Deteriorated | Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination). | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | 53 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Deterioration in Neurological Examination Findings | Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | 53 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Primary | Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) | The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment. | The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study. | Posted | | Number | | Participants | | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement. | The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF). | Posted | | Mean | 95% Confidence Interval | Score on a scale | | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement. | The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF). | Posted | | Mean | 95% Confidence Interval | Score on a scale | | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement. | The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF). | Posted | | Mean | 95% Confidence Interval | Score on a scale | | Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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| Secondary | Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score | The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale. Change = observation mean at Week 52 minus baseline mean. | The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101). | Posted | | Mean | 95% Confidence Interval | Score on a scale | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Pregabalin | Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase. |
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