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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004295-11 | EudraCT Number |
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A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo twice daily (BID) for the 6-month Treatment Period |
|
| Elagolix 150 mg QD | Experimental | Elagolix 150 mg once daily (QD) for the 6-month Treatment Period |
|
| Elagolix 200 mg BID | Experimental | Elagolix 200 mg BID for the 6-month Treatment Period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other |
| ||
| Elagolix |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. | At Month 3 of the Treatment Period |
| Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. | At Month 3 of Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 3 of the Treatment Period |
| Change From Baseline to Month 6 in DYS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28525302 | Result | Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. | |
| 34878624 |
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The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.
Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo twice daily (BID) for the 6-month Treatment Period |
| FG001 | Elagolix 150 mg QD | Elagolix 150 mg once daily (QD) for the 6-month Treatment Period |
| FG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Post-Treatment Follow-Up (PTFU) Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo BID for the 6-month Treatment Period |
| BG001 | Elagolix 150 mg QD | Elagolix 150 mg QD for the 6-month Treatment Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. | The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. | Posted | Number | percentage of participants | At Month 3 of the Treatment Period |
|
From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo BID for the 6-month Treatment Period | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C539351 | elagolix |
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|
|
The DYS pain scale ranges from 0 (none) to 3 (severe).
| Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 6 in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 3 in Dyspareunia (DYSP) | The DYSP pain scale ranges from 0 (absent) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 3 of Treatment Period |
| Percentage of Responders for Each Month, Except Month 3, in DYS | The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. | Months 1, 2, 4, 5, 6 of the Treatment Period |
| Percentage of Responders for Each Month, Except Month 3, in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. | Months 1, 2, 4, 5, 6 of the Treatment Period |
| Percentage of Responders at Each Month for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain. | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period |
| Percent Change From Baseline to Each Month in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Months 1, 2, 3, 4, 5 of Treatment Period |
| Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | Baseline, Months 1, 2, 4, 5 |
| Patient Global Impression of Change (PGIC) Questionnaire | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month, Except Month 3, in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Months 1, 3, 6 of Treatment Period |
| Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Months 1, 3, 6 of Treatment Period |
| Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | This is assessed using Health Resource Utilization Questionnaire (HRUQ). | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
| Number of Days of Hospitalization | This is assessed using HRUQ. | Up to Month 6 of Treatment Period |
| Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | This is assessed using HRUQ. | Up to Month 6 of Treatment Period |
| Derived |
| Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8. |
| 34134684 | Derived | Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3. |
| 33963686 | Derived | Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7. |
| 33650259 | Derived | Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. |
| 33564263 | Derived | Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021. |
| 33066973 | Derived | Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14. |
| 32945631 | Derived | Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8. |
| 32769633 | Derived | Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917. |
| 32621325 | Derived | Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31. |
| 31654294 | Derived | Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7. |
| 31227284 | Derived | Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. |
| 31069056 | Derived | Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019. |
| 30724096 | Derived | Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6. |
| 29476499 | Derived | Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6. |
| Subject Noncompliant |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Pregnancy |
|
| Other |
|
| Consent Withdrawn by Subject |
|
| Lost to Follow-up |
|
| Completed PTFU Month 12 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Elagolix 150 mg QD | Elagolix 150 mg QD for the 6-month Treatment Period |
| OG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
|
|
|
| Primary | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. | The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. | Posted | Number | percentage of participants | At Month 3 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of the Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | number of pills | Baseline, Month 3 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | number of pills | Baseline, Month 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 3 in Dyspareunia (DYSP) | The DYSP pain scale ranges from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | number of pills | Baseline, Month 3 of Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders for Each Month, Except Month 3, in DYS | The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point. | Posted | Number | percentage of participants | Months 1, 2, 4, 5, 6 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders for Each Month, Except Month 3, in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point. | Posted | Number | percentage of participants | Months 1, 2, 4, 5, 6 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Each Month for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point. | Posted | Number | percentage of participants | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Each Month in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Months 1, 2, 3, 4, 5 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Deviation | percentage change | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. Participants with an assessment at given timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | number of pills | Baseline, Months 1, 2, 4, 5 |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) Questionnaire | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month, Except Month 3, in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Months 1, 2, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Months 1, 3, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Months 1, 3, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
|
| Secondary | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | This is assessed using Health Resource Utilization Questionnaire (HRUQ). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. | Posted | Count of Participants | Participants | No | Months 1, 2, 3, 4, 5, 6 of Treatment Period |
|
|
|
| Secondary | Number of Days of Hospitalization | This is assessed using HRUQ. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period. | Posted | Mean | Standard Deviation | days | Up to Month 6 of Treatment Period |
|
|
|
| Secondary | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | This is assessed using HRUQ. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. | Posted | Count of Participants | Participants | No | Up to Month 6 of Treatment Period |
|
|
|
| 360 |
| 12 |
| 360 |
| 158 |
| 360 |
| EG001 | Elagolix 150 mg QD | Elagolix 150 mg QD for the 6-month Treatment Period | 1 | 226 | 12 | 226 | 128 | 226 |
| EG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period | 0 | 229 | 5 | 229 | 162 | 229 |
| FREQUENT BOWEL MOVEMENTS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| ABSCESS ORAL | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| PHARYNGEAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| JAW CYST | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
|
| ABORTION SPONTANEOUS COMPLETE | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| PERINEAL PAIN | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| BLOOD PRESSURE FLUCTUATION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| MOOD SWINGS | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| AMENORRHOEA | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Regression, Logistic |
| < 0.001 |
An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level. |
| Superiority |
| Ranked secondary efficacy endpoint 1 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -1.22 | Standard Error of the Mean | 0.156 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 2 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -1.13 | Standard Error of the Mean | 0.074 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 3 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -0.32 | Standard Error of the Mean | 0.056 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 4 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -0.18 | Standard Error of the Mean | 0.044 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 5 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -0.21 | Standard Error of the Mean | 0.048 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 6 of 7. | mixed-effects model | < 0.001 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -0.30 | Standard Error of the Mean | 0.067 | 2-Sided | Superiority |
| Ranked secondary efficacy endpoint 7 of 7. | mixed-effects model | 0.007 | For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints. | Difference in LS Mean Change | -0.08 | Standard Error of the Mean | 0.030 | 2-Sided | Superiority |
| Month 2 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| < 0.001 |
| Odds Ratio (OR) |
| 4.185 |
| 2-Sided |
| 97.5 |
| 2.707 |
| 6.469 |
| Superiority |
| Month 2 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.795 | 2-Sided | 97.5 | 1.811 | 4.312 | Superiority |
| Month 2 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 10.378 | 2-Sided | 97.5 | 6.615 | 16.282 | Superiority |
| Month 4 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 3.178 | 2-Sided | 97.5 | 2.084 | 4.845 | Superiority |
| Month 4 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 15.216 | 2-Sided | 97.5 | 9.429 | 24.554 | Superiority |
| Month 5 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.548 | 2-Sided | 97.5 | 1.683 | 3.859 | Superiority |
| Month 5 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 14.055 | 2-Sided | 97.5 | 8.716 | 22.664 | Superiority |
| Month 6 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.536 | 2-Sided | 97.5 | 1.685 | 3.816 | Superiority |
| Month 6 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 10.106 | 2-Sided | 97.5 | 6.434 | 15.874 | Superiority |
| Title | Measurements |
|---|---|
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| 0.101 |
| Odds Ratio (OR) |
| 1.376 |
| 2-Sided |
| 97.5 |
| 0.890 |
| 2.127 |
| Superiority |
| Month 2 | Regression, Logistic | 0.088 | Odds Ratio (OR) | 1.358 | 2-Sided | 97.5 | 0.909 | 2.029 | Superiority |
| Month 2 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.208 | 2-Sided | 97.5 | 1.488 | 3.278 | Superiority |
| Month 4 | Regression, Logistic | 0.003 | Odds Ratio (OR) | 1.678 | 2-Sided | 97.5 | 1.136 | 2.477 | Superiority |
| Month 4 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.722 | 2-Sided | 97.5 | 1.832 | 4.044 | Superiority |
| Month 5 | Regression, Logistic | 0.013 | Odds Ratio (OR) | 1.537 | 2-Sided | 97.5 | 1.042 | 2.267 | Superiority |
| Month 5 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.598 | 2-Sided | 97.5 | 1.750 | 3.857 | Superiority |
| Month 6 | Regression, Logistic | 0.01 | Odds Ratio (OR) | 1.565 | 2-Sided | 97.5 | 1.062 | 2.306 | Superiority |
| Month 6 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.412 | 2-Sided | 97.5 | 1.630 | 3.570 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.65 |
| Odds Ratio (OR) |
| 1.103 |
| 2-Sided |
| 97.5 |
| 0.680 |
| 1.789 |
| Superiority |
| Month 2 | Regression, Logistic | 0.154 | Odds Ratio (OR) | 1.351 | 2-Sided | 97.5 | 0.841 | 2.170 | Superiority |
| Month 2 | Regression, Logistic | 0.003 | Odds Ratio (OR) | 1.871 | 2-Sided | 97.5 | 1.175 | 2.979 | Superiority |
| Month 3 | Regression, Logistic | 0.294 | Odds Ratio (OR) | 1.250 | 2-Sided | 97.5 | 0.776 | 2.013 | Superiority |
| Month 3 | Regression, Logistic | 0.003 | Odds Ratio (OR) | 1.865 | 2-Sided | 97.5 | 1.163 | 2.989 | Superiority |
| Month 4 | Regression, Logistic | 0.521 | Odds Ratio (OR) | 1.145 | 2-Sided | 97.5 | 0.713 | 1.839 | Superiority |
| Month 4 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.474 | 2-Sided | 97.5 | 1.544 | 3.963 | Superiority |
| Month 5 | Regression, Logistic | 0.27 | Odds Ratio (OR) | 1.262 | 2-Sided | 97.5 | 0.787 | 2.023 | Superiority |
| Month 5 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 2.416 | 2-Sided | 97.5 | 1.500 | 3.891 | Superiority |
| Month 6 | Regression, Logistic | 0.953 | Odds Ratio (OR) | 1.013 | 2-Sided | 97.5 | 0.631 | 1.624 | Superiority |
| Month 6 | Regression, Logistic | < 0.001 | Odds Ratio (OR) | 1.997 | 2-Sided | 97.5 | 1.253 | 3.183 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| < 0.001 |
| LS Mean of Difference |
| -0.78 |
| Standard Error of the Mean |
| 0.071 |
| 2-Sided |
| 97.5 |
| -0.94 |
| -0.62 |
| Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.44 | Standard Error of the Mean | 0.068 | 2-Sided | 97.5 | -0.6 | -0.29 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.27 | Standard Error of the Mean | 0.068 | 2-Sided | 97.5 | -1.43 | -1.12 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.53 | Standard Error of the Mean | 0.068 | 2-Sided | 97.5 | -0.68 | -0.37 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.25 | Standard Error of the Mean | 0.067 | 2-Sided | 97.5 | -1.4 | -1.09 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.58 | Standard Error of the Mean | 0.07 | 2-Sided | 97.5 | -0.73 | -0.42 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.27 | Standard Error of the Mean | 0.07 | 2-Sided | 97.5 | -1.42 | -1.11 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.49 | Standard Error of the Mean | 0.071 | 2-Sided | 97.5 | -0.65 | -0.33 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.26 | Standard Error of the Mean | 0.071 | 2-Sided | 97.5 | -1.42 | -1.10 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| < 0.001 |
| LS Mean of Difference |
| -39.32 |
| Standard Error of the Mean |
| 3.657 |
| 2-Sided |
| 97.5 |
| -47.53 |
| -31.11 |
| Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -21.9 | Standard Error of the Mean | 3.355 | 2-Sided | 97.5 | -29.44 | -14.36 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -63.31 | Standard Error of the Mean | 3.365 | 2-Sided | 97.5 | -70.87 | -55.76 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -25.15 | Standard Error of the Mean | 3.241 | 2-Sided | 97.5 | -32.43 | -17.88 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -61.94 | Standard Error of the Mean | 3.233 | 2-Sided | 97.5 | -69.20 | -54.68 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -26.97 | Standard Error of the Mean | 3.344 | 2-Sided | 97.5 | -34.48 | -19.46 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -62.37 | Standard Error of the Mean | 3.346 | 2-Sided | 97.5 | -69.89 | -54.86 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -23.36 | Standard Error of the Mean | 3.428 | 2-Sided | 97.5 | -31.06 | -15.66 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -62.9 | Standard Error of the Mean | 3.42 | 2-Sided | 97.5 | -70.58 | -55.22 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -25.89 | Standard Error of the Mean | 3.528 | 2-Sided | 97.5 | -33.81 | -17.97 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -56.62 | Standard Error of the Mean | 3.522 | 2-Sided | 97.5 | -64.53 | -48.70 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| 0.02 |
| LS Mean of Difference |
| -0.09 |
| Standard Error of the Mean |
| 0.04 |
| 2-Sided |
| 97.5 |
| -0.18 |
| 0.00 |
| Superiority |
| Month 2 | mixed-effects model | 0.11 | LS Mean of Difference | -0.07 | Standard Error of the Mean | 0.044 | 2-Sided | 97.5 | -0.17 | 0.03 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.20 | Standard Error of the Mean | 0.043 | 2-Sided | 97.5 | -0.30 | -0.11 | Superiority |
| Month 3 | mixed-effects model | 0.041 | LS Mean of Difference | -0.10 | Standard Error of the Mean | 0.05 | 2-Sided | 97.5 | -0.22 | 0.01 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.29 | Standard Error of the Mean | 0.05 | 2-Sided | 97.5 | -0.41 | -0.18 | Superiority |
| Month 4 | mixed-effects model | 0.081 | LS Mean of Difference | -0.09 | Standard Error of the Mean | 0.052 | 2-Sided | 97.5 | -0.21 | 0.03 | Superiority |
| Month 4 | mixed-effects model | <0.001 | LS Mean of Difference | -0.33 | Standard Error of the Mean | 0.052 | 2-Sided | 97.5 | -0.45 | -0.22 | Superiority |
| Month 5 | mixed-effects model | 0.062 | LS Mean of Difference | -0.10 | Standard Error of the Mean | 0.054 | 2-Sided | 97.5 | -0.22 | 0.02 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.34 | Standard Error of the Mean | 0.054 | 2-Sided | 97.5 | -0.46 | -0.22 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.028 |
| LS Mean of Difference |
| -6.43 |
| Standard Error of the Mean |
| 2.92 |
| 2-Sided |
| 97.5 |
| -12.99 |
| 0.13 |
| Superiority |
| Month 2 | mixed-effects model | 0.082 | LS Mean of Difference | -5.17 | Standard Error of the Mean | 2.964 | 2-Sided | 97.5 | -11.82 | 1.49 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -13.19 | Standard Error of the Mean | 2.956 | 2-Sided | 97.5 | -19.83 | -6.55 | Superiority |
| Month 3 | mixed-effects model | 0.043 | LS Mean of Difference | -6.84 | Standard Error of the Mean | 3.379 | 2-Sided | 97.5 | -14.43 | 0.75 | Superiority |
| Month 3 | mixed-effects model | < 0.001 | LS Mean of Difference | -19.05 | Standard Error of the Mean | 3.364 | 2-Sided | 97.5 | -26.61 | -11.49 | Superiority |
| Month 4 | mixed-effects model | 0.072 | LS Mean of Difference | -6.25 | Standard Error of the Mean | 3.473 | 2-Sided | 97.5 | -14.05 | 1.55 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -21.58 | Standard Error of the Mean | 3.46 | 2-Sided | 97.5 | -29.35 | -13.81 | Superiority |
| Month 5 | mixed-effects model | 0.08 | LS Mean of Difference | -6.21 | Standard Error of the Mean | 3.536 | 2-Sided | 97.5 | -14.15 | 1.73 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -21.66 | Standard Error of the Mean | 3.52 | 2-Sided | 97.5 | -29.56 | -13.75 | Superiority |
| Month 6 | mixed-effects model | 0.004 | LS Mean of Difference | -10.83 | Standard Error of the Mean | 3.744 | 2-Sided | 97.5 | -19.24 | -2.43 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -21.16 | Standard Error of the Mean | 3.729 | 2-Sided | 97.5 | -29.54 | -12.79 | Superiority |
| Month 2 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.431 |
| LS Mean of Difference |
| -0.05 |
| Standard Error of the Mean |
| 0.058 |
| 2-Sided |
| 97.5 |
| -0.18 |
| 0.08 |
| Superiority |
| Month 2 | mixed-effects model | 0.277 | LS Mean of Difference | -0.07 | Standard Error of the Mean | 0.06 | 2-Sided | 97.5 | -0.20 | 0.07 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.24 | Standard Error of the Mean | 0.06 | 2-Sided | 97.5 | -0.37 | -0.10 | Superiority |
| Month 4 | mixed-effects model | 0.494 | LS Mean of Difference | -0.05 | Standard Error of the Mean | 0.071 | 2-Sided | 97.5 | -0.21 | 0.11 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.27 | Standard Error of the Mean | 0.071 | 2-Sided | 97.5 | -0.43 | -0.11 | Superiority |
| Month 5 | mixed-effects model | 0.765 | LS Mean of Difference | -0.02 | Standard Error of the Mean | 0.072 | 2-Sided | 97.5 | -0.18 | 0.14 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.31 | Standard Error of the Mean | 0.073 | 2-Sided | 97.5 | -0.47 | -0.15 | Superiority |
| Month 6 | mixed-effects model | 0.468 | LS Mean of Difference | -0.06 | Standard Deviation | 0.076 | 2-Sided | 97.5 | -0.23 | 0.12 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.33 | Standard Error of the Mean | 0.076 | 2-Sided | 97.5 | -0.50 | -0.16 | Superiority |
| Month 2 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| 0.004 |
| LS Mean of Difference |
| -0.11 |
| Standard Error of the Mean |
| 0.039 |
| 2-Sided |
| 97.5 |
| -0.20 |
| -0.03 |
| Superiority |
| Month 2 | mixed-effects model | 0.076 | LS Mean of Difference | -0.08 | Standard Error of the Mean | 0.042 | 2-Sided | 97.5 | -0.17 | 0.02 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.19 | Standard Error of the Mean | 0.042 | 2-Sided | 97.5 | -0.28 | -0.09 | Superiority |
| Month 4 | mixed-effects model | 0.058 | LS Mean of Difference | -0.09 | Standard Error of the Mean | 0.045 | 2-Sided | 97.5 | -0.19 | 0.02 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.22 | Standard Error of the Mean | 0.045 | 2-Sided | 97.5 | -0.32 | -0.12 | Superiority |
| Month 5 | mixed-effects model | 0.284 | LS Mean of Difference | -0.05 | Standard Error of the Mean | 0.049 | 2-Sided | 97.5 | -0.16 | 0.06 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.22 | Standard Error of the Mean | 0.048 | 2-Sided | 97.5 | -0.33 | -0.11 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| < 0.001 |
| LS Mean of Difference |
| -0.65 |
| Standard Error of the Mean |
| 0.099 |
| 2-Sided |
| 95 |
| -0.84 |
| -0.46 |
| Superiority |
| Month 2 | ANOVA | < 0.001 | LS Mean of Difference | -0.62 | Standard Error of the Mean | 0.102 | 2-Sided | 95 | -0.82 | -0.42 | Superiority |
| Month 2 | ANOVA | < 0.001 | LS Mean of Difference | -1.09 | Standard Error of the Mean | 0.102 | 2-Sided | 95 | -1.29 | -0.89 | Superiority |
| Month 3 | ANOVA | < 0.001 | LS Mean of Difference | -0.63 | Standard Error of the Mean | 0.106 | 2-Sided | 95 | -0.84 | -0.42 | Superiority |
| Month 3 | ANOVA | < 0.001 | LS Mean of Difference | -1.14 | Standard Error of the Mean | 0.106 | 2-Sided | 95 | -1.35 | -0.93 | Superiority |
| Month 4 | ANOVA | < 0.001 | LS Mean of Difference | -0.62 | Standard Error of the Mean | 0.109 | 2-Sided | 95 | -0.84 | -0.41 | Superiority |
| Month 4 | ANOVA | < 0.001 | LS Mean of Difference | -1.21 | Standard Error of the Mean | 0.109 | 2-Sided | 95 | -1.43 | -1.00 | Superiority |
| Month 5 | ANOVA | < 0.001 | LS Mean of Difference | -0.79 | Standard Error of the Mean | 0.113 | 2-Sided | 95 | -1.01 | -0.57 | Superiority |
| Month 5 | ANOVA | < 0.001 | LS Mean of Difference | -1.24 | Standard Error of the Mean | 0.113 | 2-Sided | 95 | -1.47 | -1.02 | Superiority |
| Month 6 | ANOVA | < 0.001 | LS Mean of Difference | -0.72 | Standard Error of the Mean | 0.116 | 2-Sided | 95 | -0.95 | -0.49 | Superiority |
| Month 6 | ANOVA | < 0.001 | LS Mean of Difference | -1.27 | Standard Error of the Mean | 0.117 | 2-Sided | 95 | -1.50 | -1.04 | Superiority |
| Month 2 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| < 0.001 |
| LS Mean of Difference |
| -0.45 |
| Standard Error of the Mean |
| 0.119 |
| 2-Sided |
| 97.5 |
| -0.72 |
| -0.18 |
| Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.54 | Standard Error of the Mean | 0.137 | 2-Sided | 97.5 | -0.85 | -0.23 | Superiority |
| Month 2 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.96 | Standard Error of the Mean | 0.137 | 2-Sided | 97.5 | -1.27 | -0.65 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.58 | Standard Error of the Mean | 0.164 | 2-Sided | 97.5 | -0.95 | -0.21 | Superiority |
| Month 4 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.36 | Standard Error of the Mean | 0.164 | 2-Sided | 97.5 | -1.72 | -0.99 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.61 | Standard Error of the Mean | 0.168 | 2-Sided | 97.5 | -0.99 | -0.23 | Superiority |
| Month 5 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.37 | Standard Error of the Mean | 0.168 | 2-Sided | 97.5 | -1.75 | -1.00 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -0.69 | Standard Error of the Mean | 0.175 | 2-Sided | 97.5 | -1.08 | -0.30 | Superiority |
| Month 6 | mixed-effects model | < 0.001 | LS Mean of Difference | -1.28 | Standard Error of the Mean | 0.175 | 2-Sided | 97.5 | -1.67 | -0.89 | Superiority |
| Month 3 |
|
|
| Month 6 |
|
|
| < 0.001 |
| Difference in LS Means |
| -7.55 |
| Standard Error of the Mean |
| 1.55 |
| 2-Sided |
| 95 |
| -10.6 |
| -4.50 |
| Superiority |
| Month 3 | ANCOVA | < 0.001 | Difference in LS Means | -7.33 | Standard Error of the Mean | 1.74 | 2-Sided | 95 | -10.75 | -3.91 | Superiority |
| Month 3 | ANCOVA | < 0.001 | Difference in LS Means | -15.43 | Standard Error of the Mean | 1.75 | 2-Sided | 95 | -18.87 | -11.99 | Superiority |
| Month 6 | ANCOVA | < 0.001 | Difference in LS Means | -8.7 | Standard Error of the Mean | 2.09 | 2-Sided | 95 | -12.81 | -4.60 | Superiority |
| Month 6 | ANCOVA | < 0.001 | Difference in LS Means | -16.92 | Standard Error of the Mean | 2.07 | 2-Sided | 95 | -20.98 | -12.86 | Superiority |
| Month 3 |
|
|
| Month 6 |
|
|
| 0.023 |
| Difference in LS Means |
| -4.40 |
| Standard Error of the Mean |
| 1.93 |
| 2-Sided |
| 95 |
| -8.19 |
| -0.61 |
| Superiority |
| Month 3 | ANCOVA | 0.257 | Difference in LS Means | -2.74 | Standard Error of the Mean | 2.42 | 2-Sided | 95 | -7.50 | 2.01 | Superiority |
| Month 3 | ANCOVA | < 0.001 | Difference in LS Means | -10.69 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | -15.37 | -6.01 | Superiority |
| Month 6 | ANCOVA | 0.315 | Difference in LS Means | -2.93 | Standard Error of the Mean | 2.91 | 2-Sided | 95 | -8.66 | 2.80 | Superiority |
| Month 6 | ANCOVA | < 0.001 | Difference in LS Means | -14.1 | Standard Error of the Mean | 2.82 | 2-Sided | 95 | -19.64 | -8.55 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.028 |
| Difference in LS Means |
| -0.95 |
| Standard Error of the Mean |
| 0.433 |
| 2-Sided |
| 95 |
| -1.80 |
| -0.10 |
| Superiority |
| Month 2 | ANCOVA | 0.014 | Difference in LS Means | -0.98 | Standard Error of the Mean | 0.397 | 2-Sided | 95 | -1.76 | -0.20 | Superiority |
| Month 2 | ANCOVA | < 0.001 | Difference in LS Means | -1.44 | Standard Error of the Mean | 0.397 | 2-Sided | 95 | -2.22 | -0.65 | Superiority |
| Month 3 | ANCOVA | 0.121 | Difference in LS Means | -0.67 | Standard Error of the Mean | 0.432 | 2-Sided | 95 | -1.52 | 0.18 | Superiority |
| Month 3 | ANCOVA | 0.001 | Difference in LS Means | -1.41 | Standard Error of the Mean | 0.431 | 2-Sided | 95 | -2.25 | -0.56 | Superiority |
| Month 4 | ANCOVA | 0.026 | Difference in LS Means | -1.25 | Standard Error of the Mean | 0.561 | 2-Sided | 95 | -2.35 | -0.15 | Superiority |
| Month 4 | ANCOVA | 0.008 | Difference in LS Means | -1.48 | Standard Error of the Mean | 0.555 | 2-Sided | 95 | -2.57 | -0.39 | Superiority |
| Month 5 | ANCOVA | 0.027 | Difference in LS Means | -0.73 | Standard Error of the Mean | 0.327 | 2-Sided | 95 | -1.37 | -0.08 | Superiority |
| Month 5 | ANCOVA | < 0.001 | Difference in LS Means | -1.11 | Standard Error of the Mean | 0.327 | 2-Sided | 95 | -1.75 | -0.47 | Superiority |
| Month 6 | ANCOVA | 0.143 | Difference in LS Means | -0.57 | Standard Error of the Mean | 0.391 | 2-Sided | 95 | -1.34 | 0.20 | Superiority |
| Month 6 | ANCOVA | 0.019 | Difference in LS Means | -0.91 | Standard Error of the Mean | 0.385 | 2-Sided | 95 | -1.67 | -0.15 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.037 |
| Difference in LS Means |
| -0.85 |
| Standard Error of the Mean |
| 0.409 |
| 2-Sided |
| 95 |
| -1.65 |
| -0.05 |
| Superiority |
| Month 2 | ANCOVA | 0.008 | Difference in LS Means | -1.12 | Standard Error of the Mean | 0.423 | 2-Sided | 95 | -1.96 | -0.29 | Superiority |
| Month 2 | ANCOVA | < 0.001 | Difference in LS Means | -1.44 | Standard Error of the Mean | 0.426 | 2-Sided | 95 | -2.27 | -0.60 | Superiority |
| Month 3 | ANCOVA | 0.036 | Difference in LS Means | -0.91 | Standard Error of the Mean | 0.434 | 2-Sided | 95 | -1.76 | -0.06 | Superiority |
| Month 3 | ANCOVA | 0.035 | Difference in LS Means | -0.91 | Standard Error of the Mean | 0.431 | 2-Sided | 95 | -1.76 | -0.06 | Superiority |
| Month 4 | ANCOVA | 0.452 | Difference in LS Means | -0.34 | Standard Error of the Mean | 0.453 | 2-Sided | 95 | -1.23 | 0.55 | Superiority |
| Month 4 | ANCOVA | 0.002 | Difference in LS Means | -1.33 | Standard Error of the Mean | 0.432 | 2-Sided | 95 | -2.18 | -0.48 | Superiority |
| Month 5 | ANCOVA | 0.012 | Difference in LS Means | -1.12 | Standard Error of the Mean | 0.443 | 2-Sided | 95 | -1.99 | -0.25 | Superiority |
| Month 5 | ANCOVA | < 0.001 | Difference in LS Means | -1.64 | Standard Error of the Mean | 0.439 | 2-Sided | 95 | -2.5 | -0.78 | Superiority |
| Month 6 | ANCOVA | 0.13 | Difference in LS Means | -0.73 | Standard Error of the Mean | 0.478 | 2-Sided | 95 | -1.67 | 0.21 | Superiority |
| Month 6 | ANCOVA | 0.001 | Difference in LS Means | -1.45 | Standard Error of the Mean | 0.454 | 2-Sided | 95 | -2.34 | -0.56 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.002 |
| Difference in LS Means |
| -3.09 |
| Standard Error of the Mean |
| 1.013 |
| 2-Sided |
| 95 |
| -5.08 |
| -1.10 |
| Superiority |
| Month 2 | ANCOVA | 0.195 | Difference in LS Means | -1.31 | Standard Error of the Mean | 1.005 | 2-Sided | 95 | -3.28 | 0.67 | Superiority |
| Month 2 | ANCOVA | < 0.001 | Difference in LS Means | -3.65 | Standard Error of the Mean | 1.007 | 2-Sided | 95 | -5.63 | -1.67 | Superiority |
| Month 3 | ANCOVA | 0.047 | Difference in LS Means | -2.03 | Standard Error of the Mean | 1.02 | 2-Sided | 95 | -4.03 | -0.02 | Superiority |
| Month 3 | ANCOVA | 0.002 | Difference in LS Means | -3.2 | Standard Error of the Mean | 1.021 | 2-Sided | 95 | -5.21 | -1.19 | Superiority |
| Month 4 | ANCOVA | 0.103 | Difference in LS Means | -1.63 | Standard Error of the Mean | 0.998 | 2-Sided | 95 | -3.59 | 0.33 | Superiority |
| Month 4 | ANCOVA | < 0.001 | Difference in LS Means | -4.78 | Standard Error of the Mean | 0.99 | 2-Sided | 95 | -6.72 | -2.83 | Superiority |
| Month 5 | ANCOVA | 0.019 | Difference in LS Means | -2.29 | Standard Error of the Mean | 0.970 | 2-Sided | 95 | -4.20 | -0.38 | Superiority |
| Month 5 | ANCOVA | < 0.001 | Difference in LS Means | -5.14 | Standard Error of the Mean | 0.975 | 2-Sided | 95 | -7.06 | -3.22 | Superiority |
| Month 6 | ANCOVA | 0.383 | Difference in LS Means | -0.97 | Standard Error of the Mean | 1.112 | 2-Sided | 95 | -3.16 | 1.22 | Superiority |
| Month 6 | ANCOVA | 0.006 | Difference in LS Means | -3.02 | Standard Error of the Mean | 1.092 | 2-Sided | 95 | -5.17 | -0.87 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.969 |
| Difference in LS Means |
| -0.02 |
| Standard Error of the Mean |
| 0.415 |
| 2-Sided |
| 95 |
| -0.83 |
| 0.80 |
| Superiority |
| Month 2 | ANCOVA | 0.569 | Difference in LS Means | -0.22 | Standard Error of the Mean | 0.389 | 2-Sided | 95 | -0.99 | 0.54 | Superiority |
| Month 2 | ANCOVA | 0.311 | Difference in LS Means | -0.4 | Standard Error of the Mean | 0.393 | 2-Sided | 95 | -1.17 | 0.37 | Superiority |
| Month 3 | ANCOVA | 0.398 | Difference in LS Means | 0.43 | Standard Error of the Mean | 0.505 | 2-Sided | 95 | -0.56 | 1.42 | Superiority |
| Month 3 | ANCOVA | 0.761 | Difference in LS Means | -0.15 | Standard Error of the Mean | 0.505 | 2-Sided | 95 | -1.15 | 0.84 | Superiority |
| Month 4 | ANCOVA | 0.874 | Difference in LS Means | 0.08 | Standard Error of the Mean | 0.491 | 2-Sided | 95 | -0.89 | 1.04 | Superiority |
| Month 4 | ANCOVA | 0.048 | Difference in LS Means | -0.93 | Standard Error of the Mean | 0.468 | 2-Sided | 95 | -1.85 | -0.01 | Superiority |
| Month 5 | ANCOVA | 0.16 | Difference in LS Means | -0.89 | Standard Error of the Mean | 0.635 | 2-Sided | 95 | -2.14 | 0.35 | Superiority |
| Month 5 | ANCOVA | 0.152 | Difference in LS Means | -0.9 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -2.14 | 0.33 | Superiority |
| Month 6 | ANCOVA | 0.095 | Difference in LS Means | -0.83 | Standard Error of the Mean | 0.498 | 2-Sided | 95 | -1.81 | 0.15 | Superiority |
| Month 6 | ANCOVA | 0.071 | Difference in LS Means | -0.86 | Standard Error of the Mean | 0.474 | 2-Sided | 95 | -1.79 | 0.07 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| < 0.001 |
| Difference in LS Means |
| -3.72 |
| Standard Error of the Mean |
| 1.113 |
| 2-Sided |
| 95 |
| -5.91 |
| -1.54 |
| Superiority |
| Month 2 | ANCOVA | 0.065 | Difference in LS Means | -2.02 | Standard Error of the Mean | 1.091 | 2-Sided | 95 | -4.16 | 0.13 | Superiority |
| Month 2 | ANCOVA | < 0.001 | Difference in LS Means | -5.1 | Standard Error of the Mean | 1.089 | 2-Sided | 95 | -7.24 | -2.96 | Superiority |
| Month 3 | ANCOVA | 0.02 | Difference in LS Means | -2.65 | Standard Error of the Mean | 1.14 | 2-Sided | 95 | -4.89 | -0.41 | Superiority |
| Month 3 | ANCOVA | < 0.001 | Difference in LS Means | -4.64 | Standard Error of the Mean | 1.135 | 2-Sided | 95 | -6.87 | -2.41 | Superiority |
| Month 4 | ANCOVA | 0.017 | Difference in LS Means | -2.72 | Standard Error of the Mean | 1.138 | 2-Sided | 95 | -4.95 | -0.48 | Superiority |
| Month 4 | ANCOVA | < 0.001 | Difference in LS Means | -6.27 | Standard Error of the Mean | 1.124 | 2-Sided | 95 | -8.48 | -4.06 | Superiority |
| Month 5 | ANCOVA | 0.023 | Difference in LS Means | -2.49 | Standard Error of the Mean | 1.095 | 2-Sided | 95 | -4.64 | -0.34 | Superiority |
| Month 5 | ANCOVA | < 0.001 | Difference in LS Means | -5.83 | Standard Error of the Mean | 1.095 | 2-Sided | 95 | -7.98 | -3.68 | Superiority |
| Month 6 | ANCOVA | 0.311 | Difference in LS Means | -1.28 | Standard Error of the Mean | 1.264 | 2-Sided | 95 | -3.77 | 1.20 | Superiority |
| Month 6 | ANCOVA | 0.001 | Difference in LS Means | -3.97 | Standard Error of the Mean | 1.241 | 2-Sided | 95 | -6.42 | -1.53 | Superiority |
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| 0.242 |
| Difference in LS Means |
| -0.72 |
| Standard Error of the Mean |
| 0.611 |
| 2-Sided |
| 95 |
| -1.91 |
| 0.48 |
| Superiority |
| Month 2 | ANCOVA | 0.042 | Difference in LS Means | -1.33 | Standard Error of the Mean | 0.652 | 2-Sided | 95 | -2.61 | -0.05 | Superiority |
| Month 2 | ANCOVA | 0.007 | Difference in LS Means | -1.77 | Standard Error of the Mean | 0.656 | 2-Sided | 95 | -3.06 | -0.48 | Superiority |
| Month 3 | ANCOVA | 0.503 | Difference in LS Means | -0.48 | Standard Error of the Mean | 0.71 | 2-Sided | 95 | -1.87 | 0.92 | Superiority |
| Month 3 | ANCOVA | 0.169 | Difference in LS Means | -0.97 | Standard Error of the Mean | 0.707 | 2-Sided | 95 | -2.36 | 0.41 | Superiority |
| Month 4 | ANCOVA | 0.675 | Difference in LS Means | -0.31 | Standard Error of the Mean | 0.737 | 2-Sided | 95 | -1.76 | 1.14 | Superiority |
| Month 4 | ANCOVA | 0.002 | Difference in LS Means | -2.17 | Standard Error of the Mean | 0.703 | 2-Sided | 95 | -3.55 | -0.79 | Superiority |
| Month 5 | ANCOVA | 0.017 | Difference in LS Means | -2.04 | Standard Error of the Mean | 0.856 | 2-Sided | 95 | -3.72 | -0.36 | Superiority |
| Month 5 | ANCOVA | 0.003 | Difference in LS Means | -2.54 | Standard Error of the Mean | 0.848 | 2-Sided | 95 | -4.21 | -0.87 | Superiority |
| Month 6 | ANCOVA | 0.042 | Difference in LS Means | -1.59 | Standard Error of the Mean | 0.778 | 2-Sided | 95 | -3.12 | -0.06 | Superiority |
| Month 6 | ANCOVA | 0.002 | Difference in LS Means | -2.28 | Standard Error of the Mean | 0.738 | 2-Sided | 95 | -3.73 | -0.83 | Superiority |
| Title | Measurements |
|---|---|
|
| Month 2 |
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| Overall |
|
| Title | Measurements |
|---|---|
|
| Angiography |
|
| Arthroscopy |
|
| Biopsy |
|
| Blood Draw |
|
| Colposcopy |
|
| Consultation |
|
| CT Scan |
|
| Diagnostic Laparoscopy |
|
| Electrocardiogram |
|
| Endometrial Ablation |
|
| Histological Exam |
|
| Intrauterine Insemination |
|
| In Vitro Fertilization |
|
| Laparoscopic Hysterectomy |
|
| Laparotomy |
|
| Magnetic Resonance Imaging |
|
| Oophorectomy |
|
| Pelvic Exam |
|
| Physical Examination |
|
| Surgery for Adhesions |
|
| Therapeutic Laparoscopy |
|
| Transfusion |
|
| Ultrasound |
|
| Urine Test |
|
| Vaginal Hysterectomy |
|
| X-Ray |
|
| Other (Not Specified) |
|