A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs

时间窗: Baseline (Day 1) up to 13 Months

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.

Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months

时间窗: Baseline up to 12 Months

Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.

Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities

时间窗: Baseline up to 12 months

Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) \>=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) \>=20 mmHg.

Number of Participants With Tanner Staging Evaluation at Baseline

时间窗: Baseline (Day 1)

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Number of Participants With Tanner Staging Evaluation at Month 12

时间窗: Month 12

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months

时间窗: Baseline up to 12 Months

In this outcome measure number of participants with increase and decrease of \>=7% in body weight, from baseline up to 12 months are reported.

Absolute Values for Body Height at Baseline

时间窗: Baseline

Absolute Values for Body Height at Month 12

时间窗: Month 12

Number of Participants With Incidence of Laboratory Abnormalities

时间窗: Baseline up to 12 Months

Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: \<0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil- absolute/%:\<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte- absolute/%:\>1.2\*ULN; total/direct/indirect bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; thyroxine, thyroid stimulating hormone \<0.8\*LLN/\>1.2\*ULN; cholesterol, triglycerides:\> \>1.3\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN, creatine kinase\>2.0\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketones, protein: \>=1, WBC, RBC:\>=20, bacteria \>20, hyaline casts/casts \>1); prothrombin (PT), PT international ratio\>1.1\*ULN.

Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters

时间窗: Baseline up to 12 Months

Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond \[msec\]) percent change (PctChg) \>=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg\>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60. 'PctChg\>=25/50%': \>= 25% increase from baseline when baseline ECG parameter is \> 200 msec, and is \>= 50% increase from baseline when baseline ECG parameter is non-missing and \<=200 msec.

28-Days Seizure Rate at Week 1

时间窗: Week 1

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 1

时间窗: Month 1

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 2

时间窗: Month 2

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 4

时间窗: Month 4

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 6

时间窗: Month 6

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 9

时间窗: Month 9

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

28-Days Seizure Rate at Month 12/Early Termination

时间窗: Month 12/Early Termination

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.