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Table 1 Numeric rating scalea changes from baseline to month 3 for integrated Elaris EM-I and II

From: Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients

Parameter

Treatment

N

LS means (SE)

LS mean of difference (SE)

97.5% CI

Two-sided p valueb

Age

      

 < 25 years

      
 

Placebo

75

 − 1.13 (0.197)

   
 

150 mg QD

55

 − 1.78 (0.242)

 − 0.65 (0.312)

(− 1.35, 0.05)

0.037*

 

200 mg BID

58

 − 1.87 (0.232)

 − 0.75 (0.304)

(− 1.43, − 0.06)

0.014*

25–35 years

      
 

Placebo

361

 − 1.06 (0.092)

   
 

150 mg QD

248

 − 1.83 (0.112)

 − 0.77 (0.144)

(− 1.09, − 0.45)

 < 0.001***

 

200 mg BID

226

 − 2.50 (0.117)

 − 1.44 (0.149)

(− 1.77, − 1.10)

 < 0.001***

 > 35 years

      
 

Placebo

205

 − 1.50 (0.123)

   
 

150 mg QD

127

 − 1.80 (0.157)

 − 0.30 (0.200)

(− 0.75, 0.15)

0.130

 

200 mg BID

138

 − 2.66 (0.151)

 − 1.16 (0.194)

(− 1.59, − 0.72)

 < 0.001***

BMI (kg/m2)

      

 < 25

      
 

Placebo

255

 − 1.31 (0.109)

   
 

150 mg QD

164

 − 1.72 (0.137)

 − 0.40 (0.175)

(− 0.79, − 0.01)

0.022*

 

200 mg BID

178

 − 2.31 (0.132)

 − 1.00 (0.171)

(− 1.38, − 0.61)

 < 0.001***

 ≥ 25–29

      
 

Placebo

178

 − 1.13 (0.130)

   
 

150 mg QD

130

 − 1.93 (0.157)

 − 0.80 (0.204)

(− 1.26, − 0.34)

 < 0.001***

 

200 mg BID

114

 − 2.79 (0.166)

 − 1.66 (0.211)

(− 2.13, − 1.18)

 < 0.001***

 ≥ 30

      
 

Placebo

205

 − 1.14 (0.124)

   
 

150 mg QD

134

 − 1.84 (0.154)

 − 0.70 (0.197)

(− 1.14, − 0.26)

 < 0.001***

 

200 mg BID

127

 − 2.36 (0.157)

 − 1.23 (0.200)

(− 1.68, − 0.78)

 < 0.001***

Race

      

White

      
 

Placebo

568

 − 1.20 (0.074)

   
 

150 mg QD

380

 − 1.78 (0.091)

 − 0.58 (0.117)

(− 0.84, − 0.31)

 < 0.001***

 

200 mg BID

376

 − 2.45 (0.091)

 − 1.24 (0.117)

(− 1.51, − 0.98)

 < 0.001***

Black

      
 

Placebo

52

 − 1.28 (0.243)

   
 

150 mg QD

38

 − 2.04 (0.289)

 − 0.76 (0.377)

(− 1.61, 0.08)

0.043*

 

200 mg BID

35

 − 2.53 (0.294)

 − 1.24 (0.381)

(− 2.10, − 0.39)

0.001***

Other

      
 

Placebo

21

 − 1.13 (0.372)

   
 

150 mg QD

12

 − 2.30 (0.524)

 − 1.17 (0.643)

(− 2.61, 0.28)

0.070

 

200 mg BID

11

 − 2.85 (0.538)

 − 1.72 (0.654)

(− 3.18, − 0.25)

0.009**

Ethnicity

      

Hispanic/latino

      
 

Placebo

92

 − 1.53 (0.181)

   
 

150 mg QD

64

 − 2.04 (0.224)

 − 0.51 (0.288)

(− 1.16, 0.14)

0.077

 

200 mg BID

64

 − 2.58 (0.220)

 − 1.05 (0.285)

(− 1.69, − 0.41)

 < 0.001***

Other

      
 

Placebo

549

 − 1.15 (0.075)

   
 

150 mg QD

366

 − 1.78 (0.092)

 − 0.63 (0.119)

(− 0.89, − 0.36)

 < 0.001***

 

200 mg BID

358

 − 2.44 (0.093)

 − 1.29 (0.120)

(− 1.56, − 1.02)

 < 0.001***

Baseline dysmenorrhea

      

 < Median = 2.17

      
 

Placebo

321

 − 1.03 (0.099)

   
 

150 mg QD

209

 − 1.67 (0.123)

 − 0.63 (0.157)

(− 0.99, − 0.28)

 < 0.001***

 

200 mg BID

220

 − 2.25 (0.121)

 − 1.22 (0.154)

(− 1.56, − 0.87)

 < 0.001***

 ≥ Median = 2.17

      
 

Placebo

320

 − 1.38 (0.099)

   
 

150 mg QD

221

 − 1.97 (0.121)

 − 0.59 (0.154)

(− 0.93, − 0.24)

 < 0.001***

 

200 mg BID

202

 − 2.70 (0.125)

 − 1.31 (0.157)

(− 1.67, − 0.96)

 < 0.001***

Baseline NMPP

      

 < Median = 1.54

      
 

Placebo

320

 − 1.04 (0.103)

   
 

150 mg QD

208

 − 1.73 (0.127)

 − 0.68 (0.157)

(− 1.04, − 0.33)

 < 0.001***

 

200 mg BID

228

 − 2.22 (0.122)

 − 1.17 (0.152)

(− 1.51, − 0.83)

 < 0.001***

 ≥ Median = 1.54

      
 

Placebo

321

 − 1.37 (0.103)

   
 

150 mg QD

222

 − 1.90 (0.124)

 − 0.53 (0.153)

(− 0.88, − 0.19)

 < 0.001***

 

200 mg BID

194

 − 2.75 (0.131)

 − 1.38 (0.160)

(− 1.74, − 1.02)

 < 0.001***

Baseline dyspareunia

      

 < Median = 1.40

      
 

Placebo

260

 − 1.09 (0.109)

   
 

150 mg QD

174

 − 1.72 (0.134)

 − 0.63 (0.172)

(− 1.02, − 0.25)

 < 0.001***

 

200 mg BID

171

 − 2.34 (0.135)

 − 1.25 (0.172)

(− 1.64, − 0.87)

 < 0.001***

 ≥ Median = 1.40

      
 

Placebo

266

 − 1.30 (0.108)

   
 

150 mg QD

181

 − 1.80 (0.133)

 − 0.50 (0.169)

(− 0.88, − 0.12)

0.003**

 

200 mg BID

169

 − 2.64 (0.136)

 − 1.33 (0.172)

(− 1.72, − 0.95)

 < 0.001***

Baseline analgesic use

      

None

      
 

Placebo

48

 − 1.47 (0.244)

   
 

150 mg QD

55

 − 1.48 (0.243)

 − 0.01 (0.344)

(− 0.78, 0.77)

0.986

 

200 mg BID

32

 − 2.88 (0.310)

 − 1.41 (0.394)

(− 2.29, − 0.53)

 < 0.001***

Opioid only

      
 

Placebo

116

 − 0.74 (0.162)

   
 

150 mg QD

77

 − 1.86 (0.205)

 − 1.12 (0.261)

(− 1.71, − 0.54)

 < 0.001***

 

200 mg BID

71

 − 2.17 (0.208)

 − 1.43 (0.264)

(− 2.02, − 0.83)

 < 0.001***

NSAID only

      
 

Placebo

212

 − 1.41 (0.120)

   
 

150 mg QD

127

 − 2.24 (0.156)

 − 0.83 (0.197)

(− 1.27, − 0.39)

 < 0.001***

 

200 mg BID

134

 − 2.49 (0.152)

 − 1.08 (0.194)

(− 1.52, − 0.65)

 < 0.001***

Both

      
 

Placebo

265

 − 1.19 (0.106)

   
 

150 mg QD

171

 − 1.58 (0.133)

 − 0.39 (0.170)

(− 0.77, − 0.01)

0.021*

 

200 mg BID

185

 − 2.49 (0.129)

 − 1.30 (0.168)

(− 1.68, − 0.93)

 < 0.001***

Time since endometriosis diagnosis

      

 < 2 years

      
 

Placebo

214

 − 1.29 (0.119)

   
 

150 mg QD

174

 − 1.66 (0.135)

 − 0.37 (0.180)

(− 0.77, 0.04)

0.042*

 

200 mg BID

138

 − 2.52 (0.151)

 − 1.23 (0.193)

(− 1.67, − 0.80)

 < 0.001***

2–5 years

      
 

Placebo

235

 − 1.16 (0.114)

   
 

150 mg QD

146

 − 1.85 (0.148)

 − 0.69 (0.187)

(− 1.11, − 0.27)

 < 0.001***

 

200 mg BID

155

 − 2.35 (0.142)

 − 1.19 (0.182)

(− 1.60, − 0.78)

 < 0.001***

 ≥ 5 years

      
 

Placebo

192

 − 1.17 (0.126)

   
 

150 mg QD

110

 − 2.02 (0.168)

 − 0.85 (0.210)

(− 1.32, − 0.38)

 < 0.001***

 

200 mg BID

128

 − 2.54 (0.157)

 − 1.37 (0.201)

(− 1.82, − 0.92)

 < 0.001***

Previous GnRH therapy

      

No

      
 

Placebo

476

 − 1.27 (0.080)

   
 

150 mg QD

319

 − 1.97 (0.099)

 − 0.70 (0.127)

(− 0.99, − 0.41)

 < 0.001***

 

200 mg BID

309

 − 2.49 (0.100)

 − 1.22 (0.128)

(− 1.51, − 0.93)

 < 0.001***

Yes

      
 

Placebo

165

 − 1.03 (0.136)

   
 

150 mg QD

111

 − 1.39 (0.167)

 − 0.36 (0.215)

(− 0.84, 0.12)

0.095

 

200 mg BID

113

 − 2.41 (0.166)

 − 1.38 (0.214)

(− 1.86, − 0.90)

 < 0.001***

Entered washout

      

No

      
 

Placebo

470

 − 1.24 (0.080)

   
 

150 mg QD

328

 − 1.86 (0.098)

 − 0.62 (0.126)

(− 0.90, − 0.33)

 < 0.001***

 

200 mg BID

316

 − 2.43 (0.099)

 − 1.19 (0.128)

(− 1.47, − 0.90)

 < 0.001***

Yes

      
 

Placebo

171

 − 1.10 (0.135)

   
 

150 mg QD

102

 − 1.66 (0.177)

 − 0.56 (0.223)

(− 1.06, − 0.06)

0.013*

 

200 mg BID

106

 − 2.58 (0.173)

 − 1.48 (0.220)

(− 1.97, − 0.99)

 < 0.001***

History of pregnancy

      

No

      
 

Placebo

278

 − 1.28 (0.099)

   
 

150 mg QD

173

 − 1.80 (0.126)

 − 0.52 (0.160)

(− 0.88, − 0.16)

0.001***

 

200 mg BID

184

 − 2.21 (0.121)

 − 0.94 (0.157)

(− 1.29, − 0.58)

 < 0.001***

Yes

      
 

Placebo

363

 − 1.15 (0.086)

   
 

150 mg QD

257

 − 1.82 (0.105)

 − 0.66 (0.135)

(− 0.97, − 0.36)

 < 0.001***

 

200 mg BID

238

 − 2.68 (0.108)

 − 1.53 (0.138)

(− 1.84, − 1.22)

 < 0.001***

  1. BID twice daily, BMI body mass index, EM-I/II Elaris endometriosis studies I and II, GnRH gonadotropin-releasing hormone, LS least squares, NMPP non-menstrual pelvic pain, NSAID non-steroidal anti-inflammatory drug, QD once daily
  2. aPain scale ranges from 0 (none) to 10 (worst pain ever)
  3. bp value for test of difference between each elagolix dosage group and placebo is from a mixed-effects model using repeated measures with treatment as the main effect, visit number as the repeated measure, baseline value, visit, subgroup, treatment by visit, subgroup by treatment, subgroup by visit, and subgroup by treatment by visit as covariates
  4. *p < 0.05, **p < 0.01, and ***p < 0.001
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