Epilepsies, Partial
Conditions
Keywords
Post-Marketing surveillance
Brief summary
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.
Detailed description
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.
Interventions
DRUGGabapentin
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Exclusion criteria
Patients not taking Gabapentin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 weeks | 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.). |
| Number of Participants With Treatment-Related Adverse Events | 12 weeks | 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.). |
| Clinical Efficacy Rate | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Ratio (R Ratio) | 12 weeks | 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. |
| Responder Rate | 12 weeks | 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. |
| Percent Reduction From Baseline in Epileptic Seizure Frequency | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | 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. |
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 12 weeks | 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. |
| Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 12 weeks | 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. |
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 12 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1,144 |
| Total | 1,144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | No Drug Administration | 4 |
| Overall Study | No Visit After First Day of Treatment | 2 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Safety Evaluation Not Assessable | 1 |
Baseline characteristics
| Characteristic | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Age, Customized <65 years | 1001 participants |
| Age, Customized >=65 years | 143 participants |
| Sex: Female, Male Female | 542 Participants |
| Sex: Female, Male Male | 602 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 248 / 1,144 |
| serious Total, serious adverse events | 29 / 1,144 |
Outcome results
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Clinical Efficacy Rate | 61.1 Percentage of 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.).
Time frame: 12 weeks
Population: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants With Treatment-Related Adverse Events | 231 participants |
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.).
Time frame: 12 weeks
Population: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 27 participants |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Percent Reduction From Baseline in Epileptic Seizure Frequency | -34.0 Percentage | Standard Deviation 103.7 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Responder Rate | 55.0 Percentage of participants |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Response Ratio (R Ratio) | -0.410 Ratio | Standard Deviation 0.4855 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 545 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 94 participants |
Comparison: The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin.p-value: <0.001Chi-squared
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 93 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 91 participants |
| Age >=25 and <35 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 102 participants |
| Age >=35 and <45 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 113 participants |
| Age >=45 and <55 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 64 participants |
| Age >=55 and <65 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 82 participants |
| Age >=65 Years | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 94 participants |
Comparison: The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin.p-value: <0.001Chi-squared
Comparison: 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.p-value: <0.001Cochran-Armitage
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 284 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 28 participants |
| Age >=25 and <35 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 4 participants |
| Age >=35 and <45 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 1 participants |
| Age >=55 and <65 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 322 participants |
Comparison: The factor tested was baseline creatinine clearance. 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 baseline creatinine clearance.p-value: =0.025Cochran-Armitage
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 432 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 166 participants |
| Age >=25 and <35 Years | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 41 participants |
Comparison: The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin.p-value: =0.018Chi-squared
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 32 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 295 participants |
| Age >=25 and <35 Years | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 190 participants |
| Age >=35 and <45 Years | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 98 participants |
| Age >=45 and <55 Years | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 24 participants |
Comparison: The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin.p-value: <0.001Chi-squared
Comparison: 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.p-value: <0.001Cochran-Armitage
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | 34 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | 605 participants |
Comparison: The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin.p-value: =0.043Chi-squared
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 150 participants |
| Age >=15 and <25 Years | Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 363 participants |
| Age >=25 and <35 Years | Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 118 participants |
Comparison: The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin.p-value: =0.008Chi-squared
Comparison: 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).p-value: =0.002Cochran-Armitage
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.
Time frame: 12 weeks
Population: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 27 participants |
| Age >=15 and <25 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 31 participants |
| Age >=25 and <35 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 52 participants |
| Age >=35 and <45 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 58 participants |
| Age >=45 and <55 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 15 participants |
| Age >=55 and <65 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 26 participants |
| Age >=65 Years | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 22 participants |
Comparison: The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin.p-value: =0.004Fisher Exact
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.
Time frame: 12 weeks
Population: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 participants |
| Age >=15 and <25 Years | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 70 participants |
| Age >=25 and <35 Years | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 91 participants |
| Age >=35 and <45 Years | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 41 participants |
| Age >=45 and <55 Years | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 17 participants |
Comparison: 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.p-value: =0.003Fisher Exact
Comparison: 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.p-value: =0.003Cochran-Armitage