Pregabalin Treatment Of Peripheral Neuropathic Pain Assoc... | NCT00407511

Label	Type	Description	Intervention Names
Pregabalin	Experimental		Drug: Pregabalin

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).

Measure	Description	Time Frame
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)	11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.	Baseline, End of Treatment

Measure	Description	Time Frame
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)	11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Bogota	Cundinamarca		Colombia
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
20487048	Derived	Xochilcal-Morales M, Castro EM, Guajardo-Rosas J, Obregon TN, Acevedo JC, Chucan JM, Plancarte-Sanchez R, Davila G, Wajsbrot D, Guerrero M, Vinueza R. A prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America. Int J Clin Pract. 2010 Aug;64(9):1301-9. doi: 10.1111/j.1742-1241.2010.02389.x. Epub 2010 May 10.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

ID	Title	Description
BG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	BG000121

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.

Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

scores on scale

Baseline, End of Treatment

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000120

Title

Denominators

Categories

Title	Measurements
	OG000-3.8± 2.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If < = 7 and > = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.	t-test, 2 sided		< 0.0001							95							Superiority or Other (legacy)

Secondary

Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.

Full Analysis Set (FAS).

Posted

Mean

Standard Deviation

scores on scale

Week 4, Week 8, Week 12

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores

Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 8, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants

Secondary

Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores

Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants

Secondary

Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 8, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 8, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants

Secondary

Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)

100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)

100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 8, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Daily Sleep Interference Score (DSIS)

Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.

Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.

Posted

Mean

Standard Deviation

scores on scale

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Patient Global Impression of Change (PGIC)

7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)

Full Analysis Set (FAS)

Posted

Number

participants

End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression of Change (CGIC)

7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).

Full Analysis Set (FAS)

Posted

Number

participants

End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)

ID	Title	Description
OG000	Pregabalin	Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Units	Counts
Participants	OG000

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000	Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-1.0	Standard Error of the Mean	0.2	95	-1.4	-0.7	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-1.8	Standard Error of the Mean	0.2	95	-2.2	-1.5	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-2.5	Standard Error of the Mean	0.2	95	-2.9	-2.2	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-2.8	Standard Error of the Mean	0.2	95	-3.2	-2.5	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-2.9	Standard Error of the Mean	0.2	95	-3.3	-2.6	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.0	Standard Error of the Mean	0.2	95	-3.4	-2.6	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.1	Standard Error of the Mean	0.2	95	-3.5	-2.8	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.2	Standard Error of the Mean	0.2	95	-3.6	-2.8	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.3	Standard Error of the Mean	0.2	95	-3.7	-2.9	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.4	Standard Error of the Mean	0.2	95	-3.7	-3.0	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.4	Standard Error of the Mean	0.2	95	-3.8	-3.0	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.	Mixed Models Analysis	< 0.0001	Mean Difference (Final Values)	-3.4	Standard Error of the Mean	0.2	95	-3.7	-3.0	Parameter estimate: Mean Difference (Final Values) = least squares mean.	Superiority or Other (legacy)
OG000	EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.	t-test, 2 sided	< 0.0001					95				Superiority or Other (legacy)

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA (v12.0)	Non-systematic Assessment	EG0001 affected121 at risk
Pericarditis	Cardiac disorders		Non-systematic Assessment	EG0001 affected121 at risk
Vitreous haemorrhage	Eye disorders		Non-systematic Assessment	EG0001 affected121 at risk
Generalized oedema	General disorders		Non-systematic Assessment	EG0001 affected121 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	EG0001 affected121 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Non-systematic Assessment	EG0001 affected121 at risk
Headache	Nervous system disorders		Non-systematic Assessment	EG0001 affected121 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry mouth	Gastrointestinal disorders	MedDRA (v12.0)	Systematic Assessment	EG0008 affected121 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0006 affected121 at risk
Oedema	General disorders		Systematic Assessment	EG0007 affected121 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG00014 affected121 at risk
Weight increased	Investigations		Systematic Assessment	EG00015 affected121 at risk
Increased appetite	Metabolism and nutrition disorders		Systematic Assessment	EG0007 affected121 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG00025 affected121 at risk
Headache	Nervous system disorders		Systematic Assessment	EG0008 affected121 at risk
Somnolence	Nervous system disorders		Systematic Assessment	EG00038 affected121 at risk

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins