Trial Outcomes & Findings for Treatment of Pain Associated With Fibromyalgia (NCT NCT02187159)

Last Updated: 2020-11-09

Results Overview

The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1270 participants

Primary outcome timeframe

Baseline up to Week 13 postdose

Results posted on

2020-11-09

Participant Flow

A total of 2280 participants who met all inclusion criteria and no exclusion criteria were enrolled from 19 Nov 2014 to 07 July 2016 at 178 sites. Of the 2280 participants enrolled, 1270 participants were randomized.

Eligible participants were randomized in a 1:1:1:1 ratio to either DS5565 15 mg QD, DS5565 15 mg BID, placebo, or pregabalin 150 mg BID.

Participant milestones

Participant milestones
Measure	Placebo Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID Participants who received DS-5565 15 mg twice daily (BID).
Overall Study STARTED	318	317	318	317
Overall Study COMPLETED	249	238	241	221
Overall Study NOT COMPLETED	69	79	77	96

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID Participants who received DS-5565 15 mg twice daily (BID).
Overall Study Protocol Violation	4	6	3	4
Overall Study Lack of Efficacy	10	5	4	7
Overall Study Adverse Event	28	33	42	50
Overall Study Withdrawal by Subject	24	28	25	26
Overall Study Other	3	7	3	9

Baseline Characteristics

Treatment of Pain Associated With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=318 Participants Participants take one each of placebo tablet and capsule BID)	Pregabalin n=317 Participants Participants take one pregabalin capsule and one placebo tablet BID	DS-5565 QD n=318 Participants Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening	DS-5565 BID n=317 Participants Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)	Total n=1270 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	289 Participants n=5 Participants	287 Participants n=7 Participants	286 Participants n=5 Participants	284 Participants n=4 Participants	1146 Participants n=21 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	30 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	124 Participants n=21 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 11.43 • n=5 Participants	50.9 years STANDARD_DEVIATION 11.58 • n=7 Participants	50.2 years STANDARD_DEVIATION 11.85 • n=5 Participants	50.6 years STANDARD_DEVIATION 11.46 • n=4 Participants	50.5 years STANDARD_DEVIATION 11.57 • n=21 Participants
Sex: Female, Male Female	290 Participants n=5 Participants	288 Participants n=7 Participants	295 Participants n=5 Participants	287 Participants n=4 Participants	1160 Participants n=21 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	23 Participants n=5 Participants	30 Participants n=4 Participants	110 Participants n=21 Participants
Region of Enrollment New Zealand	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	33 Participants n=21 Participants
Region of Enrollment Latvia	7 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment Romania	9 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	31 Participants n=21 Participants
Region of Enrollment Hungary	5 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment United States	188 Participants n=5 Participants	188 Participants n=7 Participants	188 Participants n=5 Participants	188 Participants n=4 Participants	752 Participants n=21 Participants
Region of Enrollment United Kingdom	39 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	38 Participants n=4 Participants	153 Participants n=21 Participants
Region of Enrollment Slovakia	14 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment Australia	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Bulgaria	16 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants	17 Participants n=4 Participants	74 Participants n=21 Participants
Region of Enrollment Estonia	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment India	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	44 Participants n=21 Participants
Region of Enrollment Russia	7 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment Lithuania	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: ADPS was assessed using the modified intent-to-treat (mITT) analysis set.

The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=311 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo	-1.86 units on a scale Standard Error 0.130	-2.47 units on a scale Standard Error 0.133	-2.24 units on a scale Standard Error 0.133	-2.09 units on a scale Standard Error 0.134

SECONDARY outcome

Timeframe: Week 13 postdose

Population: PGIC was assessed using the modified intent-to-treat (mITT) analysis set.

Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" (≤2 scores) are reported.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo	91 Participants	141 Participants	116 Participants	117 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: FIQ was assessed using the modified intent-to-treat (mITT) analysis set.

The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.

Outcome measures

Outcome measures
Measure	Placebo n=313 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=312 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=312 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo	-13.88 units on a scale Standard Deviation 1.20	-21.46 units on a scale Standard Deviation 1.22	-17.41 units on a scale Standard Deviation 1.22	-16.45 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Week 13 postdose

Population: Responder rates were assessed using the modified intent-to-treat (mITT) analysis set.

The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo 30% Responders	113 Participants	139 Participants	123 Participants	118 Participants
Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo 50% Responders	61 Participants	90 Participants	79 Participants	68 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: Multidimensional Fatigue Inventory (MFI-20) was assessed in the modified intent-to-treat (mITT) population.

MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.

Outcome measures

Outcome measures
Measure	Placebo n=293 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=294 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=295 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=291 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo	-1.4 units on a scale Standard Deviation 3.45	-2.8 units on a scale Standard Deviation 3.99	-2.3 units on a scale Standard Deviation 3.57	-2.1 units on a scale Standard Deviation 3.45

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: HADS was assessed using the modified intent-to-treat (mITT) analysis set.

The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13: Anxiety	-0.5 units on a scale Standard Deviation 3.43	-1.4 units on a scale Standard Deviation 3.47	-0.7 units on a scale Standard Deviation 3.30	-0.8 units on a scale Standard Deviation 3.31
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13: Depression	-0.8 units on a scale Standard Deviation 3.66	-1.6 units on a scale Standard Deviation 3.86	-1.1 units on a scale Standard Deviation 3.78	-0.8 units on a scale Standard Deviation 3.83

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: This outcome was assessed using the modified intent-to-treat analysis set.

The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13:Physical Component	4.395 units on a scale Standard Deviation 6.81	5.815 units on a scale Standard Deviation 8.03	5.000 units on a scale Standard Deviation 7.76	4.833 units on a scale Standard Deviation 7.18
Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo Change from baseline to Week 13: Mental Component	1.371 units on a scale Standard Deviation 9.43	3.093 units on a scale Standard Deviation 8.93	1.675 units on a scale Standard Deviation 9.94	1.198 units on a scale Standard Deviation 8.37

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: The EQ-5D was assessed using the modified intent-to-treat (mITT) analysis set.

The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.

Outcome measures

Outcome measures
Measure	Placebo n=293 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=292 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=295 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=291 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo	0.060 units on a scale Standard Deviation 0.18	0.10 units on a scale Standard Deviation 0.19	0.08 units on a scale Standard Deviation 0.17	0.07 units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: Pain-associated sleep interference was assessed using the modified intent-to-treat (mITT) analysis set.

Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo	-1.92 units on a scale Standard Error 0.11	-2.41 units on a scale Standard Error 0.11	-2.48 units on a scale Standard Error 0.11	-2.44 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Week 13 postdose

Population: The MOS sleep scale outcome was assessed in the modified intent-to-treat (mITT) analysis set.

The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo	90 Participants	94 Participants	101 Participants	106 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13 postdose

Population: BFI-SF was assessed using the modified intent-to-treat (mITT) analysis set.

The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Least pain	-1.4 units on a scale Standard Deviation 2.53	-1.9 units on a scale Standard Deviation 2.37	-1.5 units on a scale Standard Deviation 2.53	-1.6 units on a scale Standard Deviation 2.25
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Pain right now	-1.8 units on a scale Standard Deviation 2.76	-2.8 units on a scale Standard Deviation 2.48	-2.3 units on a scale Standard Deviation 2.54	-2.2 units on a scale Standard Deviation 2.40
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Severity score	-1.59 units on a scale Standard Deviation 2.17	-2.33 units on a scale Standard Deviation 2.08	-1.96 units on a scale Standard Deviation 2.17	-1.91 units on a scale Standard Deviation 1.95
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Normal work	-1.6 units on a scale Standard Deviation 2.65	-2.3 units on a scale Standard Deviation 2.70	-1.9 units on a scale Standard Deviation 2.77	-1.9 units on a scale Standard Deviation 2.60
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Relations with other people	-1.2 units on a scale Standard Deviation 2.92	-1.8 units on a scale Standard Deviation 2.92	-1.6 units on a scale Standard Deviation 3.12	-1.2 units on a scale Standard Deviation 2.85
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Enjoyment of life	-1.3 units on a scale Standard Deviation 3.00	-2.4 units on a scale Standard Deviation 2.85	-1.9 units on a scale Standard Deviation 3.22	-1.7 units on a scale Standard Deviation 2.98
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Mood	-1.3 units on a scale Standard Deviation 2.84	-2.2 units on a scale Standard Deviation 2.65	-1.6 units on a scale Standard Deviation 2.94	-1.6 units on a scale Standard Deviation 2.65
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Worst pain	-1.7 units on a scale Standard Deviation 2.36	-2.6 units on a scale Standard Deviation 2.37	-2.2 units on a scale Standard Deviation 2.55	-2.1 units on a scale Standard Deviation 2.30
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Average pain	-1.5 units on a scale Standard Deviation 2.13	-2.1 units on a scale Standard Deviation 2.15	-1.8 units on a scale Standard Deviation 2.15	-1.8 units on a scale Standard Deviation 1.96
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Relief (%) by treatment of pain	20.1 units on a scale Standard Deviation 33.69	31.1 units on a scale Standard Deviation 33.15	24.2 units on a scale Standard Deviation 33.26	25.9 units on a scale Standard Deviation 35.09
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Interference (%)	-14.79 units on a scale Standard Deviation 22.33	-23.76 units on a scale Standard Deviation 21.81	-19.97 units on a scale Standard Deviation 23.37	-18.35 units on a scale Standard Deviation 20.68
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo General activity	-1.6 units on a scale Standard Deviation 2.77	-2.5 units on a scale Standard Deviation 2.63	-2.1 units on a scale Standard Deviation 2.66	-2.1 units on a scale Standard Deviation 2.53
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Walking ability	-1.5 units on a scale Standard Deviation 2.60	-2.1 units on a scale Standard Deviation 2.79	-1.8 units on a scale Standard Deviation 2.88	-1.4 units on a scale Standard Deviation 2.60
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo Sleep	-1.9 units on a scale Standard Deviation 2.99	-3.3 units on a scale Standard Deviation 2.83	-3.1 units on a scale Standard Deviation 3.14	-3.0 units on a scale Standard Deviation 2.80

SECONDARY outcome

Timeframe: Week 1 to Week 13 postdose

Population: Rescue medication usage was assessed using the modified intent-to-treat (mITT) analysis set.

Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).

Outcome measures

Outcome measures
Measure	Placebo n=315 Participants Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 Participants Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 Participants Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 Participants Participants who received DS-5565 15 mg twice daily (BID).
Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo	0.23 proportion of days Standard Deviation 0.32	0.21 proportion of days Standard Deviation 0.31	0.22 proportion of days Standard Deviation 0.32	0.21 proportion of days Standard Deviation 0.31

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 206 other events

Deaths: 0 deaths

Pregabalin 150 mg BID

Serious events: 5 serious events

Other events: 299 other events

Deaths: 0 deaths

DS-5565 15 mg QD

Serious events: 7 serious events

Other events: 290 other events

Deaths: 1 deaths

DS-5565 15 mg BID

Serious events: 11 serious events

Other events: 242 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=315 participants at risk Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).	Pregabalin 150 mg BID n=312 participants at risk Participants who received oral pregabalin 150 mg twice daily (BID).	DS-5565 15 mg QD n=315 participants at risk Participants who received oral DS5565 15 mg once daily (QD).	DS-5565 15 mg BID n=313 participants at risk Participants who received DS-5565 15 mg twice daily (BID).
Investigations Weight increased	2.9% 9/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	12.5% 39/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	10.5% 33/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Nervous system disorders Headache	12.7% 40/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	11.9% 37/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	14.0% 44/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	14.4% 45/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Nervous system disorders Dizziness	7.3% 23/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	15.1% 47/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	14.0% 44/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	13.1% 41/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Nervous system disorders Somnolence	3.2% 10/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	9.3% 29/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	7.3% 23/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	9.3% 29/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Eye disorders Vision blurred	1.6% 5/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.5% 14/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.1% 16/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.2% 13/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
General disorders Drug withdrawal syndrome	6.3% 20/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	10.3% 32/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	10.2% 32/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	8.9% 28/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
General disorders Fatigue	2.9% 9/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.5% 11/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.5% 11/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
General disorders Oedema peripheral	1.3% 4/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.2% 10/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	2.9% 9/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.1% 16/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Gastrointestinal disorders Nausea	4.4% 14/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.2% 10/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.7% 18/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	8.9% 28/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Gastrointestinal disorders Diarrhoea	4.8% 15/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.8% 15/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	6.3% 20/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.5% 14/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Musculoskeletal and connective tissue disorders Fibromyalgia	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.8% 15/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.2% 10/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.1% 16/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Musculoskeletal and connective tissue disorders Back pain	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	2.6% 8/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.8% 12/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.5% 11/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Infections and infestations Nasopharyngitis	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	6.1% 19/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.4% 17/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	6.4% 20/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.
Infections and infestations Urinary tract infection	1.9% 6/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	4.2% 13/312 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	3.5% 11/315 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.	5.4% 17/313 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months. A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.

Additional Information

Daiichi Sankyo US Contact for Clinical Trial Results

Daiichi Sankyo, Inc.

Phone: 1-908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place