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Clinical Trial Results:
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

Summary
EudraCT number	2011-001412-65
Trial protocol	HU CZ PL EE SE BE FR IT BG GR NL LT FI AT SK ES GB DE HR PT DK
Global end of trial date	22 Aug 2019

Results information
Results version number	v1(current)
This version publication date	16 Feb 2020
First version publication date	16 Feb 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

A0081106

ISRCTN number

-

US NCT number

NCT01463306

WHO universal trial number (UTN)

-

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

20 Sep 2019

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

22 Aug 2019

Was the trial ended prematurely?

No

Main objective of the trial

To evaluate the long-term safety and tolerability of pregabalin in pediatric subjects 1 month through 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

21 Feb 2012

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Philippines: 89

Country: Number of subjects enrolled

Poland: 21

Country: Number of subjects enrolled

Romania: 28

Country: Number of subjects enrolled

Russian Federation: 43

Country: Number of subjects enrolled

Serbia: 21

Country: Number of subjects enrolled

Singapore: 8

Country: Number of subjects enrolled

Slovakia: 1

Country: Number of subjects enrolled

Spain: 1

Country: Number of subjects enrolled

Taiwan: 4

Country: Number of subjects enrolled

Thailand: 2

Country: Number of subjects enrolled

Turkey: 12

Country: Number of subjects enrolled

Ukraine: 162

Country: Number of subjects enrolled

United Kingdom: 4

Country: Number of subjects enrolled

United States: 35

Country: Number of subjects enrolled

Belarus: 5

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

Bosnia and Herzegovina: 4

Country: Number of subjects enrolled

Bulgaria: 31

Country: Number of subjects enrolled

China: 6

Country: Number of subjects enrolled

Czech Republic: 4

Country: Number of subjects enrolled

France: 4

Country: Number of subjects enrolled

Germany: 1

Country: Number of subjects enrolled

Greece: 2

Country: Number of subjects enrolled

Hungary: 77

Country: Number of subjects enrolled

India: 8

Country: Number of subjects enrolled

Israel: 2

Country: Number of subjects enrolled

Italy: 3

Country: Number of subjects enrolled

Korea, Republic of: 7

Country: Number of subjects enrolled

Lebanon: 6

Country: Number of subjects enrolled

Malaysia: 6

Country: Number of subjects enrolled

Montenegro: 1

Worldwide total number of subjects

605

EEA total number of subjects

184

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

60

Children (2-11 years)

291

Adolescents (12-17 years)

140

Adults (18-64 years)

114

From 65 to 84 years

0

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

Reporting arms are on basis of pediatric and adult subjects who consented to continue from previous studies receiving either pregabalin or placebo and pediatric subjects who directly enrolled in this study. Previous studies- A0081041 (NCT01389596), A0081042 (NCT02072824), A0081105 (NCT01747915).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Pregabalin: Previous and Current

Arm description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (>=) 4 years. Pediatric subjects with body weight >=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Arm type

Experimental

Investigational medicinal product name

Pregabalin

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, Oral solution

Routes of administration

Oral use

Dosage and administration details

Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day.

Placebo-Previous to Pregabalin-Current

Arm description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Arm type

Experimental

Investigational medicinal product name

Pregabalin

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, Oral solution

Routes of administration

Oral use

Dosage and administration details

Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Direct Pregabalin

Arm description

Only pediatric subjects with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.

Arm type

Experimental

Investigational medicinal product name

Pregabalin

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, Oral solution

Routes of administration

Oral use

Dosage and administration details

Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day.

Number of subjects in period 1	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Started	384	210	11
Completed	298	158	6
Not completed	86	52	5
Consent withdrawn by subject	19	9	1
Approval expiry at site	1	-	-
Death	3	3	-
Unspecified	26	13	-
Adverse Events	6	9	3
Lost to follow-up	5	2	-
Lack of efficacy	22	16	1
Protocol deviation	4	-	-

Baseline characteristics

Top of page

Reporting group title

Pregabalin: Previous and Current

Reporting group description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (>=) 4 years. Pediatric subjects with body weight >=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Placebo-Previous to Pregabalin-Current

Reporting group description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Direct Pregabalin

Reporting group description

Only pediatric subjects with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.

Reporting group values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin	Total
Number of subjects	384	210	11	605
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	37	23	0	60
Children (2-11 years)	189	97	5	291
Adolescents (12-17 years)	89	45	6	140
Adults (18-64 years)	69	45	0	114
From 65-84 years	0	0	0	0
85 years and over	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	12.56 ( 11.43 )	13.03 ( 12.39 )	11.80 ( 3.87 )	-
Sex: Female, Male
Units: Subjects
Female	176	103	7	286
Male	208	107	4	319
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0
Asian	85	47	1	133
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	1	0	4
White	294	160	9	463
More than one race	0	0	0	0
Unknown or Not Reported	2	2	1	5

End points

Top of page

Reporting group title

Pregabalin: Previous and Current

Reporting group description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (>=) 4 years. Pediatric subjects with body weight >=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Placebo-Previous to Pregabalin-Current

Reporting group description

Pediatric and adult subjects with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Direct Pregabalin

Reporting group description

Only pediatric subjects with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.

Primary: Number of Subjects With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs

Top of page

End point title

Number of Subjects With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs ^[1]

End point description

An AE was any untoward medical occurrence in a subject 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 subject who received study drug. Relatedness to study drug was assessed by the investigator. Safety population included subjects who took at least 1 dose of the study medication in the study.

End point type

Primary

End point timeframe

Baseline up to 13 Months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	384	210	11
Units: Subjects
Subjects With AEs	252	140	10
Subjects With SAEs	53	23	1
Subjects With Treatment Related AEs	104	65	9
Subjects With Treatment Related SAEs	0	1	0

No statistical analyses for this end point

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

Top of page

End point title

Number of Subjects With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months ^[2]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "n" signifies number of subjects evaluable for the specified categories.

End point type

Primary

End point timeframe

Baseline up to 12 Months

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	384	210	11
Units: Subjects
Physical Examination (n =369, 199, 9)	8	6	0
Neurological Examination (n =368, 199, 9)	10	4	2

No statistical analyses for this end point

Primary: Number of Subjects Meeting Pre-defined Criteria for Vital Signs Abnormalities

Top of page

End point title

Number of Subjects Meeting Pre-defined Criteria for Vital Signs Abnormalities ^[3]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study.

End point type

Primary

End point timeframe

Baseline up to 12 months

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	384	210	11
Units: Subjects
Max. increase from baseline in SBP>=30 mmHg\|	9	1	0
Max. decrease from baseline in SBP>=30 mmHg\|	8	5	0
Max. increase from baseline in DBP>=20 mmHg\|	34	16	1
Max. decrease from baseline in DBP>=20 mmHg\|	22	6	0

No statistical analyses for this end point

Primary: Number of Subjects With Tanner Staging Evaluation at Baseline

Top of page

End point title

Number of Subjects With Tanner Staging Evaluation at Baseline ^[4]

End point description

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Subjects are evaluated for breast development, pubic hair distribution and genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). Analysis population included subjects who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint. "n" signifies number of subjects evaluable for the specified categories.

End point type

Primary

End point timeframe

Baseline

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	213	98	9
Units: Subjects
Pubic Hair: Stage 1 (n =212, 98, 9)	95	44	4
Pubic Hair: Stage 2 (n =212, 98, 9)	34	17	1
Pubic Hair: Stage 3 (n =212, 98, 9)	33	16	0
Pubic Hair: Stage 4 (n =212, 98, 9)	34	15	0
Pubic Hair: Stage 5 (n =212, 98, 9)	16	6	2
Pubic Hair: Not Done (n =212, 98, 9)	0	0	2
Pubic Hair: Missing (n =212, 98, 9)	0	0	0
Breast: Stage 1 (n =122, 52, 6)	37	18	2
Breast: Stage 2 (n =122, 52, 6)	17	7	1
Breast: Stage 3 (n =122, 52, 6)	15	7	0
Breast: Stage 4 (n =122, 52, 6)	19	7	0
Breast: Stage 5 (n =122, 52, 6)	9	3	2
Breast: Not Done (n =122, 52, 6)	1	0	1
Breast: Missing (n =122, 52, 6)	24	9	0
Genitalia: Stage 1 (n =133, 64, 3)	50	23	2
Genitalia: Stage 2 (n =133, 64, 3)	24	11	0
Genitalia: Stage 3 (n =133, 64, 3)	20	10	0
Genitalia: Stage 4 (n =133, 64, 3)	13	7	0
Genitalia: Stage 5 (n =133, 64, 3)	7	3	0
Genitalia: Not Done (n =133, 64, 3)	0	1	1
Genitalia: Missing (n =133, 64, 3)	19	9	0

No statistical analyses for this end point

Primary: Number of Subjects With Tanner Staging Evaluation at Month 12

Top of page

End point title

Number of Subjects With Tanner Staging Evaluation at Month 12 ^[5]

End point description

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Subjects are evaluated for breast development, pubic hair distribution and genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). Analysis population included subjects who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint. "n" signifies number of subjects evaluable for the specified categories.

End point type

Primary

End point timeframe

Month 12

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	186	89	5
Units: Subjects
Pubic Hair: Stage 1 (n =186, 89, 5)	68	38	2
Pubic Hair: Stage 2 (n =186, 89, 5)	35	17	1
Pubic Hair: Stage 3 (n =186, 89, 5)	38	12	0
Pubic Hair: Stage 4 (n =186, 89, 5)	21	11	0
Pubic Hair: Stage 5 (n =186, 89, 5)	23	10	1
Pubic Hair: Not Done (n =186, 89, 5)	1	1	1
Pubic Hair: Missing (n =186, 89, 5)	0	0	0
Breast: Stage 1 (n =82, 37, 4)	27	15	2
Breast: Stage 2 (n =82, 37, 4)	17	8	1
Breast: Stage 3 (n =82, 37, 4)	19	5	0
Breast: Stage 4 (n =82, 37, 4)	7	3	0
Breast: Stage 5 (n =82, 37, 4)	12	5	1
Breast: Not Done (n =82, 37, 4)	0	1	0
Breast: Missing (n =82, 37, 4)	0	0	0
Genitalia: Stage 1 (n =104, 52, 1)	40	19	1
Genitalia: Stage 2 (n =104, 52, 1)	22	12	0
Genitalia: Stage 3 (n =104, 52, 1)	20	10	0
Genitalia: Stage 4 (n =104, 52, 1)	9	5	0
Genitalia: Stage 5 (n =104, 52, 1)	13	6	0
Genitalia: Not Done (n =104, 52,1)	82	37	4
Genitalia: Missing (n =104, 52, 1)	0	0	0

No statistical analyses for this end point

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

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End point title

Number of Subjects With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months ^[6]

End point description

In this endpoint number of subjects with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported. Safety population included subjects who took at least 1 dose of the study medication in the study. Here "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline up to 12 Months

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	377	203	9
Units: Subjects
Weight increase from baseline >=7%	290	147	8
Weight decrease from baseline >=7%	2	4	0

No statistical analyses for this end point

Primary: Absolute Values for Body Height at Baseline

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End point title

Absolute Values for Body Height at Baseline ^[7]

End point description

Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no subject was analyzed.

End point type

Primary

End point timeframe

Baseline

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	384	210	11
Units: Centimeters
arithmetic mean (standard deviation)
Age: 1 Month to <2 Years (n =37, 23, 0)	74.7 ( 7.91 )	74.8 ( 8.24 )	99999 ( 99999 )
Age: 2 Years to <4 Years (n =60, 42, 0)	92.2 ( 7.13 )	91.0 ( 8.21 )	99999 ( 99999 )
Age: 4 Years to <10 Years (n =92, 43, 4)	119.3 ( 15.16 )	118.5 ( 11.36 )	126.0 ( 12.60 )
Age: 10 Years to 16 Years (n =126, 57, 7)	153.5 ( 14.50 )	154.7 ( 11.88 )	153.4 ( 7.06 )
Age Cohort: >=17 Years (n =69, 45, 0)	170.4 ( 9.18 )	170.7 ( 9.99 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: Absolute Values for Body Height at Month 12

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End point title

Absolute Values for Body Height at Month 12 ^[8]

End point description

Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no subject was analyzed.

End point type

Primary

End point timeframe

Month 12

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	377	202	9
Units: Centimeters
arithmetic mean (standard deviation)
Age: 1 Month to <2 Years (n =36, 22 ,0)	84.4 ( 7.27 )	85.3 ( 9.01 )	99999 ( 99999 )
Age: 2 Years to <4 Years (n =58, 39, 0)	99.3 ( 7.90 )	98.1 ( 8.94 )	99999 ( 99999 )
Age: 4 Years to <10 Years (n =91, 43, 3)	128.2 ( 15.94 )	126.6 ( 10.80 )	128.2 ( 13.08 )
Age: 10 Years to 16 Years (n =125, 55, 6)	158.1 ( 13.64 )	160.5 ( 11.87 )	153.7 ( 6.58 )
Age: >=17 Years (n =67, 43, 0)	170.8 ( 9.54 )	170.6 ( 10.14 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: Number of Subjects With Incidence of Laboratory Abnormalities

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End point title

Number of Subjects With Incidence of Laboratory Abnormalities ^[9]

End point description

Hemoglobin, hematocrit, RBC count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), 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. Safety set. "Number of Subjects Analyzed”=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline up to 12 Months

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	374	204	9
Units: Subjects	297	164	8

No statistical analyses for this end point

Primary: Number of Subjects With Maximum Change from Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters

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End point title

Number of Subjects With Maximum Change from Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters ^[10]

End point description

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 is > 200, and is >= 50% increase from baseline when baseline ECG is non-missing and <=200. Safety population included subjects who took at least 1 dose of the study medication in the study. Here "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline up to 12 Months

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: bbbbNo statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	357	194	9
Units: Subjects
Max PR interval IFB PctChg >=25/50%	1	0	0
Max QRS complex IFB PctChg >=50%	0	0	0
Max QTcB interval IFB change >=30 - <60	29	11	0
Max QTcB interval IFB change >=60	0	0	0
Max QTcF interval IFB change >=30 - <60	18	9	1
Max QTcF interval IFB change >=60	1	0	0

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Week 1

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End point title

28-Days Seizure Rate at Week 1 ^[11]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Week 1

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	380	209	11
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =270, 147, 11)	102.89 ( 235.73 )	190.45 ( 1143.83 )	17.83 ( 32.18 )
PGTC (n =110, 62, 0)	2.07 ( 2.98 )	2.39 ( 4.53 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 1

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End point title

28-Days Seizure Rate at Month 1 ^[12]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 1

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	378	203	10
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =269, 142, 10)	96.39 ( 258.09 )	178.53 ( 1114.79 )	33.42 ( 54.21 )
PGTC (n =109, 61, 0)	1.43 ( 2.16 )	1.66 ( 2.86 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 2

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End point title

28-Days Seizure Rate at Month 2 ^[13]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 2

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	373	193	8
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =263, 135, 8)	79.33 ( 196.31 )	89.09 ( 579.42 )	22.16 ( 46.70 )
PGTC (n =110, 58, 0)	1.27 ( 1.80 )	1.36 ( 2.63 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 4

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End point title

28-Days Seizure Rate at Month 4 ^[14]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 4

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	352	185	6
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =247, 131, 6)	67.32 ( 190.44 )	58.33 ( 320.32 )	15.45 ( 25.23 )
PGTC (n =105, 54, 0)	1.09 ( 1.88 )	0.72 ( 0.91 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 6

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End point title

28-Days Seizure Rate at Month 6 ^[15]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 6

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	330	175	6
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =237, 124, 6)	50.18 ( 125.26 )	51.10 ( 212.59 )	4.25 ( 6.06 )
PGTC (n =93, 51, 0)	1.02 ( 1.61 )	0.79 ( 1.21 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 9

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End point title

28-Days Seizure Rate at Month 9 ^[16]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 9

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	310	164	6
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =225, 121, 6)	38.17 ( 87.75 )	43.13 ( 141.96 )	3.00 ( 3.93 )
PGTC (n =85, 43, 0)	0.96 ( 1.69 )	0.62 ( 0.99 )	99999 ( 99999 )

No statistical analyses for this end point

Primary: 28-Days Seizure Rate at Month 12/Early Termination

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End point title

28-Days Seizure Rate at Month 12/Early Termination ^[17]

End point description

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. Safety population included subjects who took at least 1 dose of the study medication in the study. Here, "Number of Subjects Analyzed" signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable for the specified categories. "99999" signifies arithmetic mean and standard deviation was not evaluated as no participants were analyzed.

End point type

Primary

End point timeframe

Month 12/Early Termination

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this endpoint

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	374	206	8
Units: Seizures Per 28-Days
arithmetic mean (standard deviation)
POS (n =266, 146, 8)	56.04 ( 147.20 )	117.88 ( 896.40 )	11.08 ( 16.55 )
PGTC (n =108, 60, 0)	1.02 ( 1.71 )	1.33 ( 3.20 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Number of Subjects With Suicidal Ideation as per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

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End point title

Number of Subjects With Suicidal Ideation as per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

End point description

Number of subjects with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", “active suicidal ideation with any methods (not plan) without intent to act”, “active suicidal ideation with some intent to act, without specific plan”, “active suicidal ideation with some intent to act, without specific plan". Safety analysis set. "Number of Subjects Analyzed”=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline (Day 1), Post-baseline on Day 1 up to 12 Months

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	258	134	10
Units: Subjects
Baseline (n =254, 132, 10)	3	2	1
Post-baseline up to 12 Months (n =257, 134, 10)	3	2	0

No statistical analyses for this end point

Secondary: Number of Subjects With Suicidal Behavior as per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

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End point title

Number of Subjects With Suicidal Behavior as per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

End point description

Number of subjects with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on “aborted attempt”, “interrupted attempt”, “preparatory acts or behavior"). Safety analysis set. "Number of Subjects Analyzed”=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline (Day 1), Post-baseline on Day 1 up to 12 Months

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	258	134	10
Units: Subjects
Screening (n =254, 132, 10)	1	1	0
Post-baseline up to 12 Months (n =257, 134, 10)	2	0	0

No statistical analyses for this end point

Secondary: Number of Subjects as per Reliable Change Index (RCI) Category for Cogstate Detection Task

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End point title

Number of Subjects as per Reliable Change Index (RCI) Category for Cogstate Detection Task

End point description

CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons.Prior tasks, subjects were briefed rules,given an interactive demonstration and a sufficient number of practice trials.For each task, subject responded “yes” using a response button with dominant hand. Subjects had to “respond as fast and as accurately as possible.”Detection task:measured simple reaction time to assess psychomotor function.Subject pressed a “YES” response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen).A subject's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),where WSD is within-subject standard deviation from Cogstate detection task normative data.Improvement in cognition when RCI <=-1.65, decline in cognition when RCI >=1.65.Safety set."Number of Subjects Analyzed”=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Month 12

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	97	51	7
Units: Subjects
Improvement (RCI <= -1.65)	21	8	2
Decline (RCI >=1.65)	13	6	1

No statistical analyses for this end point

Secondary: Number of Subjects as per Reliable Change Index Category for Cogstate Pediatric Identification Task

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End point title

Number of Subjects as per Reliable Change Index Category for Cogstate Pediatric Identification Task

End point description

CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons.Prior tasks,subjects were briefed rules,given an interactive demonstration and a sufficient number of practice trials.For each task,subject responded “yes” using a response button with dominant hand. Subjects had to “respond as fast and as accurately as possible.”Detection task: measured simple reaction time to assess psychomotor function.Subject pressed a “YES” response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen).A subject's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),where WSD is within-subject standard deviation from Cogstate detection task normative data.Improvement in cognition when RCI <=-1.65, decline in cognition when RCI >=1.65.Safety set."Number of Subjects Analyzed”=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Month 12

End point values	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Number of subjects analysed	96	50	7
Units: Subjects
Improvement (RCI <=-1.65)	17	9	2
Decline (RCI >=1.65)	16	6	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to 13 Months

Adverse event reporting additional description

Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study. Safety population was evaluated.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

Pregabalin: Previous and Current

Reporting group description

Pediatric and adult subjects included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Placebo-Previous to Pregabalin-Current

Reporting group description

Pediatric and adult subjects included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult subjects received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.

Reporting group title

Direct Pregabalin

Reporting group description

Only pediatric subjects were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric subjects with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.

Serious adverse events	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Total subjects affected by serious adverse events
subjects affected / exposed	53 / 384 (13.80%)	23 / 210 (10.95%)	1 / 11 (9.09%)
number of deaths (all causes)	3	4	0
number of deaths resulting from adverse events
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Social circumstances
Physical abuse
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	1 / 384 (0.26%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchial obstruction
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Emotional disorder
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Brain herniation
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Concussion
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epiphyseal injury
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Unintentional medical device removal
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardio-respiratory arrest
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cyanosis
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Brain oedema
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 384 (0.26%)	2 / 210 (0.95%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	3 / 384 (0.78%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postictal state
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	8 / 384 (2.08%)	6 / 210 (2.86%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 8	1 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Somnolence
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Deficiency anaemia
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gingival hypertrophy
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Saliva discolouration
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periostitis
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	3 / 384 (0.78%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear infection
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 384 (0.00%)	3 / 210 (1.43%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	17 / 384 (4.43%)	6 / 210 (2.86%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 23	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 2	0 / 0
Respiratory tract chlamydial infection
subjects affected / exposed	0 / 384 (0.00%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 384 (0.26%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systemic viral infection
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	2 / 384 (0.52%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	2 / 384 (0.52%)	1 / 210 (0.48%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Pregabalin: Previous and Current	Placebo-Previous to Pregabalin-Current	Direct Pregabalin
Total subjects affected by non serious adverse events
subjects affected / exposed	186 / 384 (48.44%)	103 / 210 (49.05%)	10 / 11 (90.91%)
Investigations
Blood triglycerides increased
subjects affected / exposed	1 / 384 (0.26%)	3 / 210 (1.43%)	1 / 11 (9.09%)
occurrences all number	1	3	1
Platelet count abnormal
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Red blood cell count abnormal
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Weight increased
subjects affected / exposed	28 / 384 (7.29%)	12 / 210 (5.71%)	2 / 11 (18.18%)
occurrences all number	29	13	2
White blood cell count abnormal
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	6 / 384 (1.56%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	7	0	1
Concussion
subjects affected / exposed	1 / 384 (0.26%)	1 / 210 (0.48%)	1 / 11 (9.09%)
occurrences all number	1	1	1
Foot fracture
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Nervous system disorders
Disturbance in attention
subjects affected / exposed	3 / 384 (0.78%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	3	2	1
Dizziness
subjects affected / exposed	19 / 384 (4.95%)	10 / 210 (4.76%)	1 / 11 (9.09%)
occurrences all number	25	11	1
Dysdiadochokinesis
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Headache
subjects affected / exposed	24 / 384 (6.25%)	8 / 210 (3.81%)	4 / 11 (36.36%)
occurrences all number	108	39	4
Lethargy
subjects affected / exposed	1 / 384 (0.26%)	1 / 210 (0.48%)	1 / 11 (9.09%)
occurrences all number	1	1	1
Psychomotor hyperactivity
subjects affected / exposed	4 / 384 (1.04%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	4	3	1
Resting tremor
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Seizure
subjects affected / exposed	22 / 384 (5.73%)	12 / 210 (5.71%)	1 / 11 (9.09%)
occurrences all number	41	13	1
Somnolence
subjects affected / exposed	26 / 384 (6.77%)	27 / 210 (12.86%)	1 / 11 (9.09%)
occurrences all number	30	33	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	8 / 384 (2.08%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	12	2	1
Pyrexia
subjects affected / exposed	54 / 384 (14.06%)	22 / 210 (10.48%)	1 / 11 (9.09%)
occurrences all number	113	35	1
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	4 / 384 (1.04%)	1 / 210 (0.48%)	2 / 11 (18.18%)
occurrences all number	8	1	2
Constipation
subjects affected / exposed	10 / 384 (2.60%)	4 / 210 (1.90%)	1 / 11 (9.09%)
occurrences all number	14	6	1
Diarrhoea
subjects affected / exposed	20 / 384 (5.21%)	9 / 210 (4.29%)	1 / 11 (9.09%)
occurrences all number	26	14	1
Vomiting
subjects affected / exposed	15 / 384 (3.91%)	11 / 210 (5.24%)	2 / 11 (18.18%)
occurrences all number	18	11	2
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	23 / 384 (5.99%)	14 / 210 (6.67%)	0 / 11 (0.00%)
occurrences all number	35	21	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	9 / 384 (2.34%)	3 / 210 (1.43%)	1 / 11 (9.09%)
occurrences all number	12	3	1
Rash macular
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Psychiatric disorders
Abnormal behaviour
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	1	0	1
Aggression
subjects affected / exposed	5 / 384 (1.30%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	6	2	1
Behaviour disorder
subjects affected / exposed	2 / 384 (0.52%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	2	2	1
Mood altered
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	1	0	1
Mood swings
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Staring
subjects affected / exposed	1 / 384 (0.26%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	1	0	1
Musculoskeletal and connective tissue disorders
Arthropathy
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Infections and infestations
Lyme disease
subjects affected / exposed	0 / 384 (0.00%)	0 / 210 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	0	1
Nasopharyngitis
subjects affected / exposed	26 / 384 (6.77%)	12 / 210 (5.71%)	0 / 11 (0.00%)
occurrences all number	38	17	0
Pneumonia
subjects affected / exposed	13 / 384 (3.39%)	12 / 210 (5.71%)	0 / 11 (0.00%)
occurrences all number	32	21	0
Sinusitis
subjects affected / exposed	2 / 384 (0.52%)	2 / 210 (0.95%)	1 / 11 (9.09%)
occurrences all number	2	2	2
Upper respiratory tract infection
subjects affected / exposed	60 / 384 (15.63%)	30 / 210 (14.29%)	0 / 11 (0.00%)
occurrences all number	113	62	0
Viral infection
subjects affected / exposed	15 / 384 (3.91%)	11 / 210 (5.24%)	0 / 11 (0.00%)
occurrences all number	20	16	0
Metabolism and nutrition disorders
Increased appetite
subjects affected / exposed	10 / 384 (2.60%)	9 / 210 (4.29%)	2 / 11 (18.18%)
occurrences all number	11	9	2

More information

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Were there any global substantial amendments to the protocol? Yes

31 Jul 2012

Safety reporting section updated due to protocol template updates.

07 May 2014

Updated to TID regimen for subjects <4 years old.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

1 death occurred in reporting arm “Placebo-Previous to Pregabalin-Current” after subject completed the study and is captured in All-cause mortality section.

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