Study Of Pregabalin (Lyrica) In Patients With Painful Dia... | NCT01057693

ID	Type	Description	Link
2009-017389-21	EudraCT Number

Label	Type	Description	Intervention Names
pregabalin (Lyrica)	Experimental		Drug: pregabalin (Lyrica)
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
pregabalin (Lyrica)	Drug	Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.	pregabalin (Lyrica)

Measure	Description	Time Frame
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline, Week 19 (DB Phase)

Measure	Description	Time Frame
Time to Loss of Pain Response (Double-Blind Phase)	Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline up to Week 19

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

Facility	Status	City	State	ZIP	Country	Contacts
Greystone Medical Research, LLC		Birmingham	Alabama	35242	United States
Neurology Clinic, PC

PubMed Identifier	Type	Citation	Retractions
23887339	Derived	Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

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

ID	Title	Description
FG000	Pregabalin SB	Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.

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 Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase

Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.

Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 19 (DB Phase)

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units	Counts
Participants	OG000147 OG001147

Title

Denominators

Categories

Single-Blind Baseline

Title	Measurements
	OG0006.8± 1.24 OG0016.7± 1.32

Change at Week 19 (DB Phase)

Title	Measurements
	OG000

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 OG001	P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.	ANCOVA		0.1221		Least Squares Mean Difference	-0.32			2-Sided	95	-0.74	0.09					Superiority or Other (legacy)

Secondary

Time to Loss of Pain Response (Double-Blind Phase)

Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.

Posted

Median

95% Confidence Interval

days

SB Baseline up to Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units	Counts
Participants

Secondary

Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase

Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. "N" (number of participants analyzed): participants who were evaluable for this measure and "n": participants who were evaluable for specified time-point. Missing data were imputed using LOCF.

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 6 (SB Phase)

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Weekly Mean Pain Scores (Single-Blind Phase)

SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time-point.

Posted

Mean

Standard Deviation

units on a scale

Week 1, 2, 3, 4, 5, 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Weekly Mean Pain Scores (Double-Blind Phase)

Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively.

Posted

Mean

Standard Deviation

units on a scale

DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)

Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)

Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.

Posted

Number

percentage of participants

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Patient Global Impression of Change (PGIC) (Single-Blind Phase)

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Patient Global Impression of Change (PGIC) (Double-Blind Phase)

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Number

participants

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units	Counts
Participants

Secondary

Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)

Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here "n" signifies participants who were evaluable for specified time-point.

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)

Posted

Mean

Standard Deviation

units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.

Posted

Number

participants

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.

Posted

Number

participants

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units

Secondary

Weekly Mean Sleep Interference Score (Single-Blind Phase)

Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point.

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 1, 2, 3, 4, 5, 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Weekly Mean Sleep Interference Score (Double-Blind Phase)

Posted

Mean

Standard Deviation

units on a scale

DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Endpoint Mean Sleep Interference Score (Single-Blind Phase)

Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Endpoint Mean Sleep Interference Score (Double-Blind Phase)

Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)

QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time point.

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)

Posted

Mean

Standard Deviation

units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Pain Visual Analog Scale (VAS) (Single-Blind Phase)

Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.

Posted

Mean

Standard Deviation

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Pain Visual Analog Scale (VAS) (Double-Blind Phase)

Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.

Posted

Mean

Standard Deviation

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units	Counts
Participants

Secondary

Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)

BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)

Posted

Mean

Standard Deviation

units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)

HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point.

Posted

Mean

Standard Deviation

units on a scale

SB Baseline, Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants

Secondary

Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)

Posted

Mean

Standard Deviation

units on a scale

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Secondary

Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)

GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.

Posted

Number

participants

Week 6

ID	Title	Description
OG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Units	Counts
Participants	OG000

Secondary

Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)

Posted

Number

participants

Week 19

ID	Title	Description
OG000	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
OG001	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Extrasystoles	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Palpitations	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Cataract	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Conjunctivitis	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Cystoid macular oedema	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Diplopia	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Dry eye	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Eye haemorrhage	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Eye pain	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Periorbital oedema	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Retinal haemorrhage	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Retinal oedema	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Retinopathy hypertensive	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Vision blurred	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Visual impairment	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Vitreous disorder	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected665 at risk EG0012 affected147 at risk EG0023 affected149 at risk
Dental caries	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected665 at risk EG0015 affected147 at risk EG0026 affected149 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected665 at risk EG0015 affected147 at risk EG0023 affected149 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Lip disorder	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00022 affected665 at risk EG0014 affected147 at risk EG0025 affected149 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0012 affected147 at risk EG0024 affected149 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk
Breakthrough pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Device breakage	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Face oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00018 affected665 at risk EG0013 affected147 at risk EG0024 affected149 at risk
Feeling abnormal	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Feeling hot	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Feeling jittery	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Foaming at mouth	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Gait disturbance	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0022 affected149 at risk
Generalised oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Implant site pruritus	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Influenza like illness	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Irritability	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Local swelling	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Malaise	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected665 at risk EG0016 affected147 at risk EG0025 affected149 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00053 affected665 at risk EG00120 affected147 at risk EG00216 affected149 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Thirst	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Seasonal allergy	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Acarodermatitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Acute sinusitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Body tinea	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0013 affected147 at risk EG0020 affected149 at risk
Candidiasis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0014 affected147 at risk EG0020 affected149 at risk
Cystitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Ear infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hordeolum	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Influenza	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0013 affected147 at risk EG0020 affected149 at risk
Localised infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0014 affected147 at risk EG0023 affected149 at risk
Oral herpes	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Postoperative wound infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Rhinitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Sinusitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0012 affected147 at risk EG0023 affected149 at risk
Skin candida	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Staphylococcal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Tinea pedis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Tooth abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Tooth infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00011 affected665 at risk EG0017 affected147 at risk EG0027 affected149 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00010 affected665 at risk EG0013 affected147 at risk EG0023 affected149 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Ear canal injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0023 affected149 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Blood amylase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Blood creatinine increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0012 affected147 at risk EG0022 affected149 at risk
Blood glucose increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Blood pressure diastolic abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Blood urea increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk
Blood uric acid increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Body temperature increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Breath sounds abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Cardiac murmur	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Haematocrit decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Heart rate increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Liver function test abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Platelet count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Urinary casts	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Urine analysis abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Weight increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00011 affected665 at risk EG0016 affected147 at risk EG0023 affected149 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Gout	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected665 at risk EG0013 affected147 at risk EG0022 affected149 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected665 at risk EG0012 affected147 at risk EG0023 affected149 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Extremity contracture	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0013 affected147 at risk EG0020 affected149 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected665 at risk EG0013 affected147 at risk EG0028 affected149 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Akathisia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Allodynia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0012 affected147 at risk EG0022 affected149 at risk
Amnesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Areflexia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Ataxia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Balance disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Burning sensation	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Coordination abnormal	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Decreased vibratory sense	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected665 at risk EG0011 affected147 at risk EG0022 affected149 at risk
Disturbance in attention	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00045 affected665 at risk EG0014 affected147 at risk EG0022 affected149 at risk
Dizziness postural	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00029 affected665 at risk EG0014 affected147 at risk EG0024 affected149 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0012 affected147 at risk EG0024 affected149 at risk
Hypersomnia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected665 at risk EG0011 affected147 at risk EG0022 affected149 at risk
Lethargy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Memory impairment	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Migraine	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Neuralgia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Poor quality sleep	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Presyncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Sedation	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Sensory disturbance	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Sinus headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Somnolence	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00038 affected665 at risk EG0016 affected147 at risk EG0025 affected149 at risk
Tension headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Tremor	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Agitation	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Anorgasmia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Bradyphrenia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected665 at risk EG0012 affected147 at risk EG0022 affected149 at risk
Depressive symptom	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Disorientation	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Euphoric mood	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Libido decreased	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Mood swings	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Nervousness	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Nightmare	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Sleep disorder	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Thinking abnormal	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Nocturia	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Renal pain	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0021 affected149 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0011 affected147 at risk EG0022 affected149 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Nail hypertrophy	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0010 affected147 at risk EG0022 affected149 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0010 affected147 at risk EG0020 affected149 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Skin tightness	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0012 affected147 at risk EG0021 affected149 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected665 at risk EG0011 affected147 at risk EG0020 affected149 at risk
Intermittent claudication	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0010 affected147 at risk EG0021 affected149 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected665 at risk EG0012 affected147 at risk EG0020 affected149 at risk

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pregabalin SB	Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.	17	665	331	665
EG001	Pregabalin DB	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.	11	147	86	147
EG002	Placebo	Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.	6	149	94	149