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The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin (Lyrica) capsule | Patients administered "Pregabalin capsule". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin (Lyrica) capsule | Drug | Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily". |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reaction | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. | 13 weeks at maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Drug Reaction | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | LYRICA Capsules (Pregabalin) | Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Among 3827 participants whose survey form was collected, a total of 214 participants were excluded from the baseline analysis population due to following reasons: protocol violation (26 participants), no drug administration information (2 participants), and no visit after treatment (186 participants).
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| ID | Title | Description |
|---|---|---|
| BG000 | LYRICA Capsules (Pregabalin) | Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| 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 With Adverse Drug Reaction | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Percentage of Participants | 13 weeks at maximum |
|
13 weeks at maximum
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events 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 | LYRICA Capsules (Pregabalin) | Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gangrene | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2013 | Jul 23, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2018 | Jul 23, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
|
| 13 weeks at maximum |
| The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. | 13 weeks at maximum |
| Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. | 13 weeks at maximum |
| Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. | 13 weeks at maximum |
| Number of Participants With Adverse Drug Reactions Related to Vision-related Events | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. | 13 weeks at maximum |
| Clinical Effectiveness Rate | Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 13 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | At Week 13 |
| Change From Baseline in Participant-rated Pain Score at Week 13 | The pain experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | Baseline and at Week 13 |
| Change From Baseline in Participant-rated Sleep Interference Score at Week 13 | The sleep interference (inability to sleep because of pain) experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | Baseline and at Week 13 |
| Patient's Impression (PGIC) at Week 13 | The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | At Week 13 |
| Physician's Impression (CGIC) at Week 13 | The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | At Week 13 |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Serious Adverse Drug Reaction | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Percentage of Participants | 13 weeks at maximum |
|
|
|
| Secondary | The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Percentage of Participants | 13 weeks at maximum |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Participants | 13 weeks at maximum |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Participants | 13 weeks at maximum |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions Related to Vision-related Events | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Posted | Number | Participants | 13 weeks at maximum |
|
|
|
| Secondary | Clinical Effectiveness Rate | Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 13 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of clinical effectiveness was available and who satisfied the inclusion criteria among the baseline analysis population. Of these, participants evaluated as "impossible to judge" were excluded from the analysis population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 13 |
|
|
|
| Secondary | Change From Baseline in Participant-rated Pain Score at Week 13 | The pain experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated pain score was available and who satisfied the inclusion criteria among the baseline analysis population. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and at Week 13 |
|
|
|
| Secondary | Change From Baseline in Participant-rated Sleep Interference Score at Week 13 | The sleep interference (inability to sleep because of pain) experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated sleep interference score was available and who satisfied the inclusion criteria among the baseline analysis population. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and at Week 13 |
|
|
|
| Secondary | Patient's Impression (PGIC) at Week 13 | The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available and who satisfied the inclusion criteria among the baseline analysis population. | Posted | Number | Participants | At Week 13 |
|
|
|
| Secondary | Physician's Impression (CGIC) at Week 13 | The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available and who satisfied the inclusion criteria among the baseline analysis population. | Posted | Number | Participants | At Week 13 |
|
|
|
| 17 |
| 3,613 |
| 77 |
| 3,613 |
| 636 |
| 3,613 |
| Herpes virus infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Decreased immune responsiveness | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Somatic symptom disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Drug interaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Device breakage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Accommodation disorder | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Loss of control of legs | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema due to cardiac disease | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic enzyme abnormal | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysstasia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Radicular pain | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Fixed eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 20.0 | 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.
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| Unchanged |
|
| Slightly worsened |
|
| Worsened |
|
| Markedly worsened |
|
| Not assessed |
|
| Title | Measurements |
|---|---|
|
| Unchanged |
|
| Slightly worsened |
|
| Worsened |
|
| Markedly worsened |
|
| Not assessed |
|