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This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
continuous patients with target disorders in collaborating institutions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy |
| ||
| Neuropathic Pain |
| ||
| Fibromyalgia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin (Lyrica) | Drug | Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population | Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. | Baseline through Week 12 |
| Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population | Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. | Baseline through Week 12 |
| Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. | Baseline through Week 12 |
| Percentage of Participants With Improvement in Seizure Frequency in PP Population | Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. | Baseline through Week 12 |
| Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6 | Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | Baseline and Week 6 |
| Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6 | Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. |
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Inclusion Criteria:
Exclusion Criteria:
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Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use
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| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin: Epilepsy | Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy. |
| BG001 | Pregabalin: Neuropathic Pain |
| 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 | Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population | Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. | ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Week 12 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009437 | Neuralgia |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
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|
| pregabalin (Lyrica) | Drug | Peripheral neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Central neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 1 week, and if needed, to a maximum dose of 600 mg per day after an additional 1 week interval. In case that tolerability could not be shown in the targeted daily dose, dose reduction may be considered. |
|
| pregabalin (Lyrica) | Drug | The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Subjects who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Treatment with doses above 450 mg/day is not recommended. |
|
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
| Baseline and Week 6 |
| Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6 | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | Baseline and Week 6 |
| Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6 | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | Baseline and Week 6 |
| Baseline and Week 6 |
| Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | Baseline and Week 6 |
| Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | Baseline and Week 6 |
| Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | Baseline and Week 6 |
| Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With CGIC Scale for NeP in PP Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With PGIC Scale for NeP in PP Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With CGIC Scale for Fibromyalgia in PP Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Number of Participants With PGIC Scale for Fibromyalgia in PP Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | Week 6 |
| Lack of Efficacy |
|
| Death |
|
| Randomized but not treated |
|
Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
| BG002 | Pregabalin: Fibromyalgia | Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population | Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. | PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Week 12 |
|
|
|
| Primary | Percentage of Participants With Improvement in Seizure Frequency in ITT Population | Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. | ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy. | Posted | Number | Percentage of participants | Baseline through Week 12 |
|
|
|
| Primary | Percentage of Participants With Improvement in Seizure Frequency in PP Population | Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. | PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy. | Posted | Number | Percentage of participants | Baseline through Week 12 |
|
|
|
| Primary | Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6 | Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Primary | Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6 | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Primary | Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6 | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Primary | Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6 | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6 | Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6 | DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With CGIC Scale for NeP in PP Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With PGIC Scale for NeP in PP Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With CGIC Scale for Fibromyalgia in ITT Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With CGIC Scale for Fibromyalgia in PP Population | CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With PGIC Scale for Fibromyalgia in ITT Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia. | Posted | Number | Participants | Week 6 |
|
|
|
| Secondary | Number of Participants With PGIC Scale for Fibromyalgia in PP Population | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. | PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia. | Posted | Number | Participants | Week 6 |
|
|
|
| 2 |
| 4,174 |
| 190 |
| 4,174 |
| Pneumonia | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Worsening |
|
| Title | Measurements |
|---|---|
|
| Worsening |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|