Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Patients taking Gabapentin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan. Dosage, frequency: According to Japanese LPD, "Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg)". Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.). | 12 weeks |
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.). | 12 weeks |
| Clinical Efficacy Rate | Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Ratio (R Ratio) | Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events. | 12 weeks |
Inclusion Criteria:
Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Exclusion Criteria:
Patients not taking Gabapentin
Not provided
Not provided
Not provided
Not provided
The patients whom an investigator involving A9451163 prescribes the Gabapentin
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
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin 200, 300, 400 mg Tablets | The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
In total, 1194 participants were enrolled in the study. Of the 1194 participants, a total of 50 participants were excluded from the baseline analysis for the following reasons: protocol violation, lost to follow-up, no visit after first day of treatment, no drug administration, and safety evaluation "Not Assessable".
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin 200, 300, 400 mg Tablets | The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert. |
| 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 of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.). | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | Posted | Number | participants | 12 weeks |
|
12 weeks
The frequency of adverse events. 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.
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 | Gabapentin 200, 300, 400 mg Tablets | The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased activity | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12 weeks |
| Responder Rate | Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more. | 12 weeks |
| Percent Reduction From Baseline in Epileptic Seizure Frequency | Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100. | 12 weeks |
| Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy. | 12 weeks |
| Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy. | 12 weeks |
| No Drug Administration |
|
| Safety Evaluation "Not Assessable" |
|
| Number |
| participants |
|
| Sex: Female, Male | Participants taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert. | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.). | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | Posted | Number | participants | 12 weeks |
|
|
|
| Primary | Clinical Efficacy Rate | Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
|
|
| Secondary | Response Ratio (R Ratio) | Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure. | R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Posted | Mean | Standard Deviation | Ratio | 12 weeks |
|
|
|
| Secondary | Responder Rate | Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more. | Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
|
|
| Secondary | Percent Reduction From Baseline in Epileptic Seizure Frequency | Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100. | The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population. | Posted | Mean | Standard Deviation | Percentage | 12 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events. | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events. | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy. | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | Posted | Number | participants | 12 weeks |
|
|
|
|
| 29 |
| 1,144 |
| 248 |
| 1,144 |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
|
| Nasal sinus cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Vogt-Koyanagi-Harada syndrome | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | 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.
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
The risk factor tested was "number of concomitant antiepileptic drugs at baseline". The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline. |
| Cochran-Armitage |
| =0.003 |
| Superiority or Other (legacy) |
The factor tested was "age". The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories. |
| Cochran-Armitage |
| <0.001 |
| Superiority or Other (legacy) |
The factor tested was "severity of partial epileptic seizure". The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe). |
| Cochran-Armitage |
| =0.002 |
| Superiority or Other (legacy) |
The factor tested was "number of concomitant antiepileptic drugs at baseline". The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline. |
| Cochran-Armitage |
| <0.001 |
| Superiority or Other (legacy) |