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This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label | This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 75-150 mg BID for at least 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken. | Baseline through Final Visit (Week 4) |
| Discontinuations Due to Adverse Events | Discontinuations due to adverse events by MedDRA system organ class and preferred term. | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS) Score | Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline. | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
Male or female, 18 years and above diagnosed with neuropathic pain.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) | Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken. | Safety population: all subjects who took at least 1 dose of study medication. | Posted | Number | participants | Baseline through Final Visit (Week 4) |
|
Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
| VAS Pain Score at Baseline (BL) and Second Visit | VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit . | Baseline, Second Visit (Week ≥ 2) |
| VAS Pain Score at Baseline and Final Visit | VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit. | Baseline, Final Visit (Week 4) |
| Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit. | Second Visit (Week ≥ 2), Final Visit (Week 4) |
| Other |
|
| Adverse Event |
|
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Score | Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit. | Posted | Mean | Standard Deviation | scores on scale | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | VAS Pain Score at Baseline (BL) and Second Visit | VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit . | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Baseline, Second Visit (Week ≥ 2) |
|
|
|
| Secondary | VAS Pain Score at Baseline and Final Visit | VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Baseline, Final Visit (Week 4) |
|
|
|
| Secondary | Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits | Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit | Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist | Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Secondary | Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit | Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit. | Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population. | Posted | Number | participants | Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| Primary | Discontinuations Due to Adverse Events | Discontinuations due to adverse events by MedDRA system organ class and preferred term. | Safety population: all subjects who took at least one dose of study medication. | Posted | Number | participants | Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) |
|
|
|
| 7 |
| 2,278 |
| 345 |
| 2,278 |
| Multi-organ failure | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Incoherent | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain |
|
| BL: Mild Pain (n= 25); 2nd Visit: Missing |
|
| BL: Moderate Pain (n=450); 2nd Visit: Mild Pain |
|
| BL: Moderate Pain (n=450): 2nd Visit: Mod Pain |
|
| BL: Moderate Pain (n=450); 2nd Visit: Severe Pain |
|
| BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain |
|
| BL: Moderate Pain (n=450); 2nd Visit: Missing |
|
| BL: Severe Pain (n=985); 2nd Visit: Mild Pain |
|
| BL: Severe Pain (n=985); 2nd Visit: Moderate Pain |
|
| BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain |
|
| BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain |
|
| BL: Severe Pain (n=985); 2nd Visit: Missing |
|
| BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain |
|
| BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain |
|
| BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain |
|
| BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn |
|
| BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing |
|
| BL: Missing (n=45); 2nd Visit: Mild Pain |
|
| BL: Missing (n=45) ; 2nd Visit: Moderate Pain |
|
| BL: Missing (n=45) ; 2nd Visit: Severe Pain |
|
| BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain |
|
| BL: Missing (n=45); 2nd Visit: Missing |
|
| Title | Measurements |
|---|---|
|
| BL: Mild Pain (n=25); Final Visit: Missing |
|
| BL: Moderate Pain (n=450); Final Visit: Mild Pain |
|
| BL: Moderate Pain (n=450); Final Visit: Mod. Pain |
|
| BL: Moderate Pain (n=450); Final Visit: Sev. Pain |
|
| BL: Moderate Pain (n=450); Final Visit: Missing |
|
| BL: Severe Pain (n=985); Final Visit: Mild Pain |
|
| BL: Severe Pain (n=985); Final Visit: Mod. Pain |
|
| BL: Severe Pain (n=985); Final Visit: Severe Pain |
|
| BL: Severe Pain (n=985); Final Visit: Missing |
|
| BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain |
|
| BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain |
|
| BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain |
|
| BL: Worst Poss. Pain (n=98); Final Visit: Missing |
|
| BL: Missing (n=45); Final Visit: Mild Pain |
|
| BL: Missing (n=45); Final Visit: Moderate Pain |
|
| BL: Missing (n=45); Final Visit: Severe Pain |
|
| BL: Missing (n=45); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=272); Final Visit: Fair |
|
| 2nd Visit: Excellent (n=272); Final Visit: Poor |
|
| 2nd Visit: Excellent (n=272); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=803); Final Vst: Excellent |
|
| 2nd Visit: Very Good (n=803); Final Vst: Very Good |
|
| 2nd Visit: Very Good (n=803); Final Visit: Good |
|
| 2nd Visit: Very Good (n=803); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=803); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=803); Final Visit: Missing |
|
| 2nd Visit: Good (n=438); Final Visit: Excellent |
|
| 2nd Visit: Good (n=438); Final Visit: Very Good |
|
| 2nd Visit: Good (n=438); Final Visit: Good |
|
| 2nd Visit: Good (n=438); Final Visit: Fair |
|
| 2nd Visit: Good (n=438); Final Visit: Poor |
|
| 2nd Visit: Good (n=438); Final Visit: Missing |
|
| 2nd Visit: Fair (n=71); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=71); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=71); Final Visit: Good |
|
| 2nd Visit: Fair (n=71); Final Visit: Fair |
|
| 2nd Visit: Fair (n=71); Final Visit: Poor |
|
| 2nd Visit: Fair (n=71); Final Visit: Missing |
|
| 2nd Visit: Poor (n=7); Final Visit: Excellent |
|
| 2nd Visit: Poor (n=7); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=7); Final Visit: Good |
|
| 2nd Visit: Poor (n=7); Final Visit: Fair |
|
| 2nd Visit: Poor (n=7); Final Visit: Poor |
|
| 2nd Visit: Poor (n=7); Final Visit: Missing |
|
| 2nd Visit: Missing (n=12); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=12); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=12); Final Visit: Good |
|
| 2nd Visit: Missing (n=12); Final Visit: Fair |
|
| 2nd Visit: Missing (n=12); Final Visit: Poor |
|
| 2nd Visit: Missing (n=12); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=260) ; Final Visit: Fair |
|
| 2nd Visit: Excellent (n=260) ; Final Visit: Poor |
|
| 2nd Visit: Excellent (n=260); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=778); Final Visit: Excell |
|
| 2nd Visit: Very Good (n=778); Final Vst: Very Good |
|
| 2nd Visit: Very Good (n=778); Final Visit: Good |
|
| 2nd Visit: Very Good (n=778); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=778); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=778); Final Visit: Missing |
|
| 2nd Visit: Good (n=454); Final Visit: Excellent |
|
| 2nd Visit: Good (n=454); Final Visit: Very Good |
|
| 2nd Visit: Good (n=454); Final Visit: Good |
|
| 2nd Visit: Good (n=454); Final Visit: Fair |
|
| 2nd Visit: Good (n=454); Final Visit: Poor |
|
| 2nd Visit: Good (n=454); Final Visit: Missing |
|
| 2nd Visit: Fair (n=81); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=81); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=81); Final Visit:: Good |
|
| 2nd Visit: Fair (n=81); Final Visit: Fair |
|
| 2nd Visit: Fair (n=81); Final Visit: Poor |
|
| 2nd Visit: Fair (n=81); Final Visit: Missing |
|
| 2nd Visit: Poor (n=12); Final Visit: Excellent |
|
| 2nd Visit: Poor (n=12); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=12); Final Visit: Good |
|
| 2nd Visit: Poor (n=12); Final Visit: Fair |
|
| 2nd Visit::Poor (n=12); Final Visit: Poor |
|
| 2nd Visit: Poor (n=12); Final Visit: Missing |
|
| 2nd Visit: Missing (n=18); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=18); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=18); Final Visit: Good |
|
| 2nd Visit: Missing (n=18); Final Visit: Fair |
|
| 2nd Visit: Missing (n=18); Final Visit: Poor |
|
| 2nd Visit: Missing (n=18); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=279); Final Visit: Fair |
|
| 2nd Visit: Excellent (n=279); Final Visit: Poor |
|
| 2nd Visit: Excellent (n=279); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=813); Final Visit: Excell |
|
| 2nd Visit: Very Good (n=813); Final Vst: Very Good |
|
| 2nd Visit: Very Good (n=813); Final Visit: Good |
|
| 2nd Visit: Very Good (n=813); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=813); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=813); Final Visit: Missing |
|
| 2nd Visit: Good (n=418); Final Visit: Excellent |
|
| 2nd Visit: Good (n=418); Final Visit: Very Good |
|
| 2nd Visit: Good (n=418); Final Visit: Good |
|
| 2nd Visit: Good (n=418); Final Visit: Fair |
|
| 2nd Visit: Good (n=418); Final Visit: Poor |
|
| 2nd Visit: Good (n=418); Final Visit: Missing |
|
| 2nd Visit: Fair (n=66); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=66); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=66); Final Visit: Good |
|
| 2nd Visit: Fair (n=66); Final Visit: Fair |
|
| 2nd Visit: Fair (n=66); Final Visit: Poor |
|
| 2nd Visit: Fair (n=66); Final Visit: Missing |
|
| 2nd Visit: Poor (n=7); Final Visit: Excellent |
|
| 2nd Visit: Poor (n=7); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=7); Final Visit: Good |
|
| 2nd Visit: Poor (n=7); Final Visit: Fair |
|
| 2nd Visit: Poor (n=7); Final Visit: Poor |
|
| 2nd Visit: Poor (n=7); Final Visit: Missing |
|
| 2nd Visit: Missing (n=20); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=20); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=20); Final Visit: Good |
|
| 2nd Visit: Missing (n=20); Final Visit: Fair |
|
| 2nd Visit: Missing (n=20); Final Visit: Poor |
|
| 2nd Visit: Missing (n=20); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=264); Final Visit: Fair |
|
| 2nd Visit: Excellent (n=264); Final Visit: Poor |
|
| 2nd Visit: Excellent (n=264); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=775); Final Visit: Excell |
|
| 2nd Visit: Very Good (n=775); Final Vst: Very Good |
|
| 2nd Visit: Very Good (n=775); Final Visit: Good |
|
| 2nd Visit: Very Good (n=775); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=775); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=775); Final Visit: Missing |
|
| 2nd Visit: Good (n=450); Final Visit: Excellent |
|
| 2nd Visit: Good (n=450): Final Visit: Very Good |
|
| 2nd Visit: Good (n=450); Final Visit: Good |
|
| 2nd Visit: Good (n=450); Final Visit: Fair |
|
| 2nd Visit: Good (n=450); Final Visit: Poor |
|
| 2nd Visit: Good (n=450); Final Visit: Missing |
|
| 2nd Visit: Fair (n=75); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=75); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=75); Final Visit: Good |
|
| 2nd Visit: Fair (n=75); Final Visit: Fair |
|
| 2nd Visit: Fair (n=75); Final Visit: Poor |
|
| 2nd Visit: Fair (n=75); Final Visit: Missing |
|
| 2nd Visit: Poor (n=12); Final Visit: Excellent |
|
| 2nd Visit :Poor (n=12); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=12); Final Visit: Good |
|
| 2nd Visit: Poor (n=12); Final Visit: Fair |
|
| 2nd Visit: Poor (n=12); Final Visit: Poor |
|
| 2nd Visit: Poor (n=12); Final Visit: Missing |
|
| 2nd Visit: Missing (n=27); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=27); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=27); Final Visit: Good |
|
| 2nd Visit: Missing (n=27); Final Visit: Fair |
|
| 2nd Visit: Missing (n=27); Final Visit: Poor |
|
| 2nd Visit: Missing (n=27); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=309); Final Visit: Fair |
|
| 2nd Visit: Excellent (n=309); Final Visit: Poor |
|
| 2nd Visit: Excellent (n=309); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=764); Final Visit: Excell |
|
| 2nd Visit: Very Good (n=764); Final Vst:Very Good |
|
| 2nd Visit: Very Good (n=764); Final Visit: Good |
|
| 2nd Visit: Very Good (n=764); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=764); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=764); Final Visit: Missing |
|
| 2nd Visit: Good (n=436); Final Visit: Excellent |
|
| 2nd Visit: Good (n=436); Final Visit: Very Good |
|
| 2nd Visit: Good (n=436); Final Visit: Good |
|
| 2nd Visit: Good (n=436); Final Visit: Fair |
|
| 2nd Visit: Good (n=436); Final Visit: Poor |
|
| 2nd Visit: Good (n=436); Final Visit: Missing |
|
| 2nd Visit: Fair (n=67); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=67); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=67); Final Visit: Good |
|
| 2nd Visit: Fair (n=67); Final Visit: Fair |
|
| 2nd Visit: Fair (n=67); Final Visit: Poor |
|
| 2nd Visit: Fair (n=67); Final Visit: Missing |
|
| 2nd Visit: Poor (n=6); Final Visit: Excellent |
|
| 2nd Visit: Poor (n=6); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=6); Final Visit: Good |
|
| 2nd Visit: Poor (n=6); Final Visit: Fair |
|
| 2nd Visit: Poor (n=6); Final Visit: Poor |
|
| 2nd Visit: Poor (n=6); Final Visit: Missing |
|
| 2nd Visit: Missing (n=21); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=21); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=21); Final Visit: Good |
|
| 2nd Visit: Missing (n=21); Final Visit: Fair |
|
| 2nd Visit: Missing (n=21); Final Visit: Poor |
|
| 2nd Visit: Missing (n=21); Final Visit: Missing |
|
|
| 2nd Visit: Excellent (n=278); Final Visit: Fair |
|
| 2nd Visit: Excellent (n=278); Final Visit: Poor |
|
| 2nd Visit: Excellent (n=278); Final Visit: Missing |
|
| 2nd Visit: Very Good (n=750); Final Visit: Excell |
|
| 2nd Visit: Very Good (n=750); Final Vst: Very Good |
|
| 2nd Visit: Very Good (n=750); Final Visit: Good |
|
| 2nd Visit: Very Good (n=750); Final Visit: Fair |
|
| 2nd Visit: Very Good (n=750); Final Visit: Poor |
|
| 2nd Visit: Very Good (n=750); Final Visit: Missing |
|
| 2nd Visit: Good (n=465); Final Visit: Excellent |
|
| 2nd Visit: Good (n=465); Final Visit: Very Good |
|
| 2nd Visit: Good (n=465); Final Visit: Good |
|
| 2nd Visit: Good (n=465); Final Visit: Fair |
|
| 2nd Visit: Good (n=465); Final Visit: Poor |
|
| 2nd Visit: Good (n=465); Final Visit: Missing |
|
| 2nd Visit: Fair (n=71); Final Visit: Excellent |
|
| 2nd Visit: Fair (n=71); Final Visit: Very Good |
|
| 2nd Visit: Fair (n=71); Final Visit: Good |
|
| 2nd Visit: Fair (n=71); Final Visit: Fair |
|
| 2nd Visit: Fair (n=71); Final Visit: Poor |
|
| 2nd Visit: Fair (n=71); Final Visit: Missing |
|
| 2nd Visit: Poor (n=11); Final Visit: Excellent |
|
| 2nd Visit: Poor (n=11); Final Visit: Very Good |
|
| 2nd Visit: Poor (n=11); Final Visit: Good |
|
| 2nd Visit: Poor (n=11); Final Visit: Fair |
|
| 2nd Visit: Poor (n=11); Final Visit: Poor |
|
| 2nd Visit: Poor (n=11); Final Visit: Missing |
|
| 2nd Visit: Missing (n=28); Final Visit: Excellent |
|
| 2nd Visit: Missing (n=28); Final Visit: Very Good |
|
| 2nd Visit: Missing (n=28); Final Visit: Good |
|
| 2nd Visit: Missing (n=28); Final Visit: Fair |
|
| 2nd Visit: Missing (n=28); Final Visit: Poor |
|
| 2nd Visit: Missing (n=28); Final Visit: Missing |
|
| Title | Measurements |
|---|---|
|
| Gastrointestinal Disorders: vomiting |
|
| General/ Administrative Site Conditions: asthenia |
|
| Nervous System Disorders: somnolence |
|
| Resp., Thoracic & Mediastinal Disorders: snoring |
|
| Vascular Disorders: hypertension |
|