Endometriosis
Conditions
Keywords
Endometriosis, pain, tanezumab, nerve growth factor, questionnaires
Brief summary
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
Interventions
BIOLOGICALTanezumab
15 mg IV single dose
DRUGPlacebo
Placebo IV single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years. * Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.
Exclusion criteria
* Previous hysterectomy * Surgical treatment for endometriosis within last 6 months. * Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months * Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed). * Any history of malignant disease (cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Baseline, Week 8 | Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Endometriosis pain during menstruation was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain. |
| Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Non-menstrual endometriosis pain was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) on the non-menstrual days for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain. |
| Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Participants assessed worst endometriosis pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit. |
| Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Participants assessed worst endometriosis pain during menstruation in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period preceding the post-baseline visit. |
| Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Participants assessed worst endometriosis non-menstrual pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period preceding the post-baseline visit. |
| Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Pain related to sexual intercourse was defined as the discomfort or pain that may occur during or after sexual intercourse with vaginal penetration. Participants assessed pain during or after sexual intercourse on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit. |
| Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Investigator assessed the severity of the dysmenorrhea (menstrual pain), pelvic pain and dyspareunia (painful sexual intercourse) experienced by participants occurring during the most recent menstrual cycle on a 4-point scale, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Total score was calculated as a sum of the individual pain scores for dysmenorrhea, dyspareunia and pelvic pain. The total score range: 0 (no pain) to 9 (worst possible pain). |
| Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline and Week 8 | EHP-30 is a validated quality of life (QoL) scale assessing emotional, physical and sexual function. EHP-30 consists of 30 items that assess the frequency of physical and mental manifestations of endometriosis during the previous 4 weeks on a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).. Scores for 6 domains (pain, control and powerlessness, emotional well-being, social support, self image, and sexual intercourse) were obtained as a sum of all relevant item scores and transformed to a 0 to 100 score range. Each domain score ranges from 0 (best possible health status) to 100 (worst possible health status). |
| Global Response Assessment (GRA) at Week 8 | Week 8 | GRA questionnaire is a 7-point symmetric scale which measures participant-reported overall response to treatment compared to baseline as 1 of the following possible responses: markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved, and markedly improved. Number of participants with each response is reported. |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Weeks 4, 12, and 16 | Participants assessed daily endometriosis pain on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit. |
| Participant Global Preference at Week 8 | Week 8 | Participant global preference is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant reported previous treatment under following categories: hormonal contraceptive, painkiller, and hormone treatment by injection, hormone treatment by tablet, surgery, and no treatment. Participant preference was assessed using following categories: definitely prefer study medication, slightly prefer study medication, no preference, slightly prefer previous treatment, and definitely prefer previous treatment. Number of participants under each of the categories is reported. For previous treatment, a single participant may be represented in more than 1 category. |
| Participant Willingness to Re-use Study Medication | Week 8 | Participant willingness to re-use study medication is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, definitely would not want to re-use. |
| Plasma Nerve Growth Factor (NGF) Concentration | Day 1, Week 8, and Week 16 (End of Treatment) | — |
| Amount of Rescue Medication Used | Baseline, Weeks 4, 8, 12, and 16 | Mean amount of daily rescue medication (acetaminophen 500 mg tablet/capsule) taken for endometriosis associated pain (in mg) was assessed. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 113 days after last dose of study medication | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 113 days after last dose that were absent before treatment or worsened relative to pre-treatment state. |
| Number of Participants With New or Worsened Neurological Examinations | Weeks 2, 4, 8, 12, and 16 | A neurological evaluation was performed by a consulting neurologist if adverse events suggested new or worsening peripheral neuropathy with respect to baseline or any adverse event of abnormal peripheral sensation was recorded. A neurological evaluation was done as soon as the above signs and symptoms were known, preferably within 7 days of becoming aware of such problems if possible. Neurological evaluation was done using Neuropathy Impairment Score (NIS) by investigator. Neurologic examination assessment included strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes. Abnormality was judged by the investigator. |
| Number of Participants With Anti-Drug Antibody (ADA) | Day 1 (pre-dose), Weeks 2, 4, 8, and 16 | Serum samples were analyzed for the presence or absence of anti-tanezumab antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). |
| Number of Participants With Positive Urine or Serum Pregnancy Test | Screening, Weeks 2, 4, 8, 12, and Early termination | — |
| Participant Global Satisfaction at Week 8 | Week 8 | Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant's response is rated on a 5-point scale where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. Number of participants with each response is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16. | 22 |
| Placebo A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16. | 25 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Randomized but not Treated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Tanezumab | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 6.7 | 30.4 years STANDARD_DEVIATION 6.4 | 30.2 years STANDARD_DEVIATION 6.4 |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 22 | 21 / 25 |
| serious Total, serious adverse events | 0 / 22 | 3 / 25 |
Outcome results
Primary
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Time frame: Baseline, Week 8
Population: Restricted full analysis set (rFAS) included all randomized participants who received at least 1 dose of study medication and completed \>=12 days of baseline observation period and who had provided baseline and primary efficacy data for \>=12 days of the baseline and \>=15 days of each of first 2 post-randomization 28-day observation periods.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Baseline | 5.45 units on a scale | Standard Deviation 1.218 |
| Tanezumab | Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Change at Week 8 | -2.88 units on a scale | Standard Deviation 2.653 |
| Placebo | Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Baseline | 5.50 units on a scale | Standard Deviation 1.363 |
| Placebo | Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Change at Week 8 | -3.51 units on a scale | Standard Deviation 1.714 |
Comparison: Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.90% CI: [-0.87, 1.69]
Secondary
Amount of Rescue Medication Used
Mean amount of daily rescue medication (acetaminophen 500 mg tablet/capsule) taken for endometriosis associated pain (in mg) was assessed.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Amount of Rescue Medication Used | Week 4 | 41.78 mg/day | Standard Deviation 38.69 |
| Tanezumab | Amount of Rescue Medication Used | Week 12 | 21.25 mg/day | Standard Deviation 20.57 |
| Tanezumab | Amount of Rescue Medication Used | Week 8 | 34.73 mg/day | Standard Deviation 37.21 |
| Tanezumab | Amount of Rescue Medication Used | Week 16 | 24.13 mg/day | Standard Deviation 27.33 |
| Tanezumab | Amount of Rescue Medication Used | Baseline | 66.78 mg/day | Standard Deviation 34.6 |
| Placebo | Amount of Rescue Medication Used | Week 16 | 28.40 mg/day | Standard Deviation 25.81 |
| Placebo | Amount of Rescue Medication Used | Baseline | 56.60 mg/day | Standard Deviation 61.39 |
| Placebo | Amount of Rescue Medication Used | Week 4 | 48.86 mg/day | Standard Deviation 50.57 |
| Placebo | Amount of Rescue Medication Used | Week 8 | 43.20 mg/day | Standard Deviation 28.95 |
| Placebo | Amount of Rescue Medication Used | Week 12 | 29.33 mg/day | Standard Deviation 28.09 |
Secondary
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16
Participants assessed daily endometriosis pain on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Time frame: Weeks 4, 12, and 16
Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 4 | 3.55 units on a scale | Standard Deviation 1.999 |
| Tanezumab | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 12 | 2.22 units on a scale | Standard Deviation 2.113 |
| Tanezumab | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 16 | 3.12 units on a scale | Standard Deviation 2.32 |
| Placebo | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 4 | 2.94 units on a scale | Standard Deviation 1.814 |
| Placebo | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 12 | 1.45 units on a scale | Standard Deviation 1.631 |
| Placebo | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Week 16 | 2.15 units on a scale | Standard Deviation 2.338 |
Secondary
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Endometriosis pain during menstruation was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.98 units on a scale | Standard Deviation 2.503 |
| Tanezumab | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.92 units on a scale | Standard Deviation 2.801 |
| Tanezumab | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.99 units on a scale | Standard Deviation 2.724 |
| Tanezumab | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 4.66 units on a scale | Standard Deviation 2.297 |
| Tanezumab | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.04 units on a scale | Standard Deviation 1.377 |
| Placebo | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 2.94 units on a scale | Standard Deviation 2.847 |
| Placebo | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.54 units on a scale | Standard Deviation 1.756 |
| Placebo | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.72 units on a scale | Standard Deviation 2.155 |
| Placebo | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.18 units on a scale | Standard Deviation 1.54 |
| Placebo | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 1.52 units on a scale | Standard Deviation 2.117 |
Secondary
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Non-menstrual endometriosis pain was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) on the non-menstrual days for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.42 units on a scale | Standard Deviation 1.935 |
| Tanezumab | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 1.98 units on a scale | Standard Deviation 2.124 |
| Tanezumab | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.38 units on a scale | Standard Deviation 2.24 |
| Tanezumab | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 2.86 units on a scale | Standard Deviation 2.341 |
| Tanezumab | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 5.25 units on a scale | Standard Deviation 1.617 |
| Placebo | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 1.91 units on a scale | Standard Deviation 2.288 |
| Placebo | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 5.21 units on a scale | Standard Deviation 1.348 |
| Placebo | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 2.77 units on a scale | Standard Deviation 1.885 |
| Placebo | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 1.81 units on a scale | Standard Deviation 2.038 |
| Placebo | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 1.33 units on a scale | Standard Deviation 1.513 |
Secondary
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16
Pain related to sexual intercourse was defined as the discomfort or pain that may occur during or after sexual intercourse with vaginal penetration. Participants assessed pain during or after sexual intercourse on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.32 units on a scale | Standard Deviation 2.687 |
| Tanezumab | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.99 units on a scale | Standard Deviation 2.485 |
| Tanezumab | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.70 units on a scale | Standard Deviation 2.884 |
| Tanezumab | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.29 units on a scale | Standard Deviation 2.976 |
| Tanezumab | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 5.21 units on a scale | Standard Deviation 3.209 |
| Placebo | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.05 units on a scale | Standard Deviation 2.442 |
| Placebo | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 5.19 units on a scale | Standard Deviation 2.757 |
| Placebo | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.03 units on a scale | Standard Deviation 2.298 |
| Placebo | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.92 units on a scale | Standard Deviation 2.869 |
| Placebo | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.57 units on a scale | Standard Deviation 2.337 |
Secondary
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8
EHP-30 is a validated quality of life (QoL) scale assessing emotional, physical and sexual function. EHP-30 consists of 30 items that assess the frequency of physical and mental manifestations of endometriosis during the previous 4 weeks on a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).. Scores for 6 domains (pain, control and powerlessness, emotional well-being, social support, self image, and sexual intercourse) were obtained as a sum of all relevant item scores and transformed to a 0 to 100 score range. Each domain score ranges from 0 (best possible health status) to 100 (worst possible health status).
Time frame: Baseline and Week 8
Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable for specified category for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Pain | 58.97 units on a scale | Standard Deviation 14.661 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Control & Powerlessness | 69.96 units on a scale | Standard Deviation 20.25 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Emotional well-being | 52.85 units on a scale | Standard Deviation 18.005 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Social support | 57.57 units on a scale | Standard Deviation 24.701 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Self-image | 53.51 units on a scale | Standard Deviation 29.7 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Sexual intercourse | 58.93 units on a scale | Standard Deviation 37.835 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Pain | 28.34 units on a scale | Standard Deviation 17.179 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Control & Powerlessness | 28.92 units on a scale | Standard Deviation 20.437 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Emotional well-being | 27.94 units on a scale | Standard Deviation 17.664 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Social support | 36.33 units on a scale | Standard Deviation 28.706 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Self-image | 31.86 units on a scale | Standard Deviation 23.613 |
| Tanezumab | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Sexual intercourse | 45.45 units on a scale | Standard Deviation 32.822 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Self-image | 24.40 units on a scale | Standard Deviation 27.632 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Pain | 56.68 units on a scale | Standard Deviation 13.213 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Pain | 26.30 units on a scale | Standard Deviation 23.325 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Control & Powerlessness | 64.84 units on a scale | Standard Deviation 22.098 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Social support | 26.34 units on a scale | Standard Deviation 30.636 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Emotional well-being | 41.15 units on a scale | Standard Deviation 21.671 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Control & Powerlessness | 27.98 units on a scale | Standard Deviation 34.298 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Social support | 46.48 units on a scale | Standard Deviation 26.018 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Sexual intercourse | 29.20 units on a scale | Standard Deviation 31.654 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Self-image | 45.31 units on a scale | Standard Deviation 27.55 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Week 8: Emotional well-being | 16.37 units on a scale | Standard Deviation 19.3 |
| Placebo | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline: Sexual intercourse | 65.36 units on a scale | Standard Deviation 23.49 |
Secondary
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16
Investigator assessed the severity of the dysmenorrhea (menstrual pain), pelvic pain and dyspareunia (painful sexual intercourse) experienced by participants occurring during the most recent menstrual cycle on a 4-point scale, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Total score was calculated as a sum of the individual pain scores for dysmenorrhea, dyspareunia and pelvic pain. The total score range: 0 (no pain) to 9 (worst possible pain).
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 7.08 units on a scale | Standard Deviation 1.379 |
| Tanezumab | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 3.42 units on a scale | Standard Deviation 2.575 |
| Tanezumab | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 5.00 units on a scale | Standard Deviation 1.871 |
| Tanezumab | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 4.83 units on a scale | Standard Deviation 3.07 |
| Tanezumab | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.89 units on a scale | Standard Deviation 2.571 |
| Placebo | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.17 units on a scale | Standard Deviation 2.791 |
| Placebo | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 7.00 units on a scale | Standard Deviation 1.109 |
| Placebo | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 3.83 units on a scale | Standard Deviation 2.443 |
| Placebo | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.63 units on a scale | Standard Deviation 1.996 |
| Placebo | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 4.58 units on a scale | Standard Deviation 2.712 |
Secondary
Global Response Assessment (GRA) at Week 8
GRA questionnaire is a 7-point symmetric scale which measures participant-reported overall response to treatment compared to baseline as 1 of the following possible responses: markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved, and markedly improved. Number of participants with each response is reported.
Time frame: Week 8
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Slightly Worse | 0 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Slightly Improved | 4 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Moderately Worse | 0 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Moderately Improved | 8 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | No Change | 3 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Markedly Improved | 2 Participants |
| Tanezumab | Global Response Assessment (GRA) at Week 8 | Markedly Worse | 0 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Markedly Improved | 3 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Markedly Worse | 1 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Moderately Worse | 0 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Slightly Worse | 0 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | No Change | 2 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Slightly Improved | 2 Participants |
| Placebo | Global Response Assessment (GRA) at Week 8 | Moderately Improved | 6 Participants |
Secondary
Number of Participants With Anti-Drug Antibody (ADA)
Serum samples were analyzed for the presence or absence of anti-tanezumab antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA).
Time frame: Day 1 (pre-dose), Weeks 2, 4, 8, and 16
Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable at specified time point. Only participants who received tanezumab were planned to be analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 2 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Day 1 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 4 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 8 | 0 Participants |
| Tanezumab | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
Secondary
Number of Participants With New or Worsened Neurological Examinations
A neurological evaluation was performed by a consulting neurologist if adverse events suggested new or worsening peripheral neuropathy with respect to baseline or any adverse event of abnormal peripheral sensation was recorded. A neurological evaluation was done as soon as the above signs and symptoms were known, preferably within 7 days of becoming aware of such problems if possible. Neurological evaluation was done using Neuropathy Impairment Score (NIS) by investigator. Neurologic examination assessment included strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes. Abnormality was judged by the investigator.
Time frame: Weeks 2, 4, 8, 12, and 16
Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With New or Worsened Neurological Examinations | Week 4 | 0 Participants |
| Tanezumab | Number of Participants With New or Worsened Neurological Examinations | Week 12 | 1 Participants |
| Tanezumab | Number of Participants With New or Worsened Neurological Examinations | Week 8 | 1 Participants |
| Tanezumab | Number of Participants With New or Worsened Neurological Examinations | Week 16 | 1 Participants |
| Tanezumab | Number of Participants With New or Worsened Neurological Examinations | Week 2 | 3 Participants |
| Placebo | Number of Participants With New or Worsened Neurological Examinations | Week 16 | 0 Participants |
| Placebo | Number of Participants With New or Worsened Neurological Examinations | Week 2 | 1 Participants |
| Placebo | Number of Participants With New or Worsened Neurological Examinations | Week 4 | 0 Participants |
| Placebo | Number of Participants With New or Worsened Neurological Examinations | Week 8 | 1 Participants |
| Placebo | Number of Participants With New or Worsened Neurological Examinations | Week 12 | 2 Participants |
Secondary
Number of Participants With Positive Urine or Serum Pregnancy Test
Time frame: Screening, Weeks 2, 4, 8, 12, and Early termination
Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Placebo | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 113 days after last dose that were absent before treatment or worsened relative to pre-treatment state.
Time frame: Baseline up to 113 days after last dose of study medication
Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 16 Participants |
| Tanezumab | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 21 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Secondary
Participant Global Preference at Week 8
Participant global preference is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant reported previous treatment under following categories: hormonal contraceptive, painkiller, and hormone treatment by injection, hormone treatment by tablet, surgery, and no treatment. Participant preference was assessed using following categories: definitely prefer study medication, slightly prefer study medication, no preference, slightly prefer previous treatment, and definitely prefer previous treatment. Number of participants under each of the categories is reported. For previous treatment, a single participant may be represented in more than 1 category.
Time frame: Week 8
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Participant Global Preference at Week 8 | Hormone treatment by tablet | 1 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Definitely prefer study medication | 11 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Hormone treatment by injection | 1 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Slightly prefer study medication | 3 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Surgery | 5 Participants |
| Tanezumab | Participant Global Preference at Week 8 | No preference | 0 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Painkiller | 11 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Slightly prefer previous treatment | 1 Participants |
| Tanezumab | Participant Global Preference at Week 8 | No treatment | 4 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Definitely prefer previous treatment | 2 Participants |
| Tanezumab | Participant Global Preference at Week 8 | Hormonal contraceptive | 7 Participants |
| Placebo | Participant Global Preference at Week 8 | Definitely prefer previous treatment | 2 Participants |
| Placebo | Participant Global Preference at Week 8 | Hormonal contraceptive | 7 Participants |
| Placebo | Participant Global Preference at Week 8 | Painkiller | 7 Participants |
| Placebo | Participant Global Preference at Week 8 | Hormone treatment by injection | 1 Participants |
| Placebo | Participant Global Preference at Week 8 | Hormone treatment by tablet | 0 Participants |
| Placebo | Participant Global Preference at Week 8 | Surgery | 5 Participants |
| Placebo | Participant Global Preference at Week 8 | No treatment | 1 Participants |
| Placebo | Participant Global Preference at Week 8 | Definitely prefer study medication | 6 Participants |
| Placebo | Participant Global Preference at Week 8 | Slightly prefer study medication | 3 Participants |
| Placebo | Participant Global Preference at Week 8 | No preference | 2 Participants |
| Placebo | Participant Global Preference at Week 8 | Slightly prefer previous treatment | 1 Participants |
Secondary
Participant Global Satisfaction at Week 8
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant's response is rated on a 5-point scale where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. Number of participants with each response is reported.
Time frame: Week 8
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Participant Global Satisfaction at Week 8 | Dissatisfied | 0 Participants |
| Tanezumab | Participant Global Satisfaction at Week 8 | Satisfied | 7 Participants |
| Tanezumab | Participant Global Satisfaction at Week 8 | Extremely dissatisfied | 0 Participants |
| Tanezumab | Participant Global Satisfaction at Week 8 | Neither satisfied nor dissatisfied | 5 Participants |
| Tanezumab | Participant Global Satisfaction at Week 8 | Extremely satisfied | 5 Participants |
| Placebo | Participant Global Satisfaction at Week 8 | Extremely dissatisfied | 2 Participants |
| Placebo | Participant Global Satisfaction at Week 8 | Dissatisfied | 0 Participants |
| Placebo | Participant Global Satisfaction at Week 8 | Extremely satisfied | 3 Participants |
| Placebo | Participant Global Satisfaction at Week 8 | Satisfied | 7 Participants |
| Placebo | Participant Global Satisfaction at Week 8 | Neither satisfied nor dissatisfied | 2 Participants |
Secondary
Participant Willingness to Re-use Study Medication
Participant willingness to re-use study medication is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, definitely would not want to re-use.
Time frame: Week 8
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Participant Willingness to Re-use Study Medication | Might want to re-use | 1 Participants |
| Tanezumab | Participant Willingness to Re-use Study Medication | Might not want to re-use | 1 Participants |
| Tanezumab | Participant Willingness to Re-use Study Medication | Not sure | 2 Participants |
| Tanezumab | Participant Willingness to Re-use Study Medication | Definitely would not want to re-use | 0 Participants |
| Tanezumab | Participant Willingness to Re-use Study Medication | Definitely want to re-use | 13 Participants |
| Placebo | Participant Willingness to Re-use Study Medication | Definitely would not want to re-use | 2 Participants |
| Placebo | Participant Willingness to Re-use Study Medication | Definitely want to re-use | 7 Participants |
| Placebo | Participant Willingness to Re-use Study Medication | Might want to re-use | 1 Participants |
| Placebo | Participant Willingness to Re-use Study Medication | Not sure | 3 Participants |
| Placebo | Participant Willingness to Re-use Study Medication | Might not want to re-use | 1 Participants |
Secondary
Plasma Nerve Growth Factor (NGF) Concentration
Time frame: Day 1, Week 8, and Week 16 (End of Treatment)
Population: FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Plasma Nerve Growth Factor (NGF) Concentration | Day 1 | 301 picogram per milliliter (pg/mL) | Standard Deviation 1217 |
| Tanezumab | Plasma Nerve Growth Factor (NGF) Concentration | Week 8 | 4053 picogram per milliliter (pg/mL) | Standard Deviation 1276 |
| Tanezumab | Plasma Nerve Growth Factor (NGF) Concentration | Week 16 | 3010 picogram per milliliter (pg/mL) | Standard Deviation 921 |
| Placebo | Plasma Nerve Growth Factor (NGF) Concentration | Day 1 | 32.7 picogram per milliliter (pg/mL) | Standard Deviation 10.6 |
| Placebo | Plasma Nerve Growth Factor (NGF) Concentration | Week 8 | 30.7 picogram per milliliter (pg/mL) | Standard Deviation 7.8 |
| Placebo | Plasma Nerve Growth Factor (NGF) Concentration | Week 16 | 31.4 picogram per milliliter (pg/mL) | Standard Deviation 10.6 |
Secondary
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 3.20 units on a scale | Standard Deviation 2.465 |
| Tanezumab | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 4.21 units on a scale | Standard Deviation 2.053 |
| Tanezumab | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 3.02 units on a scale | Standard Deviation 2.612 |
| Tanezumab | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.87 units on a scale | Standard Deviation 2.477 |
| Tanezumab | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.20 units on a scale | Standard Deviation 1.265 |
| Placebo | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.12 units on a scale | Standard Deviation 2.818 |
| Placebo | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.84 units on a scale | Standard Deviation 1.297 |
| Placebo | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 4.00 units on a scale | Standard Deviation 2.216 |
| Placebo | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.64 units on a scale | Standard Deviation 2.373 |
| Placebo | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.18 units on a scale | Standard Deviation 2.465 |
Secondary
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis pain during menstruation in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period preceding the post-baseline visit.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 5.54 units on a scale | Standard Deviation 2.752 |
| Tanezumab | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.98 units on a scale | Standard Deviation 1.084 |
| Tanezumab | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 4.78 units on a scale | Standard Deviation 2.532 |
| Tanezumab | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 3.60 units on a scale | Standard Deviation 3.022 |
| Tanezumab | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 3.58 units on a scale | Standard Deviation 3.198 |
| Placebo | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.34 units on a scale | Standard Deviation 3.072 |
| Placebo | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 3.19 units on a scale | Standard Deviation 2.356 |
| Placebo | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 7.67 units on a scale | Standard Deviation 1.632 |
| Placebo | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 4.03 units on a scale | Standard Deviation 3.306 |
| Placebo | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 5.02 units on a scale | Standard Deviation 2.488 |
Secondary
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis non-menstrual pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period preceding the post-baseline visit.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 4.06 units on a scale | Standard Deviation 2.038 |
| Tanezumab | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.79 units on a scale | Standard Deviation 2.646 |
| Tanezumab | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.99 units on a scale | Standard Deviation 2.331 |
| Tanezumab | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 3.61 units on a scale | Standard Deviation 2.475 |
| Tanezumab | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 5.86 units on a scale | Standard Deviation 1.629 |
| Placebo | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 16 | 2.85 units on a scale | Standard Deviation 2.807 |
| Placebo | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline | 6.60 units on a scale | Standard Deviation 1.299 |
| Placebo | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 4 | 3.75 units on a scale | Standard Deviation 2.36 |
| Placebo | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 8 | 2.37 units on a scale | Standard Deviation 2.527 |
| Placebo | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Week 12 | 2.03 units on a scale | Standard Deviation 2.358 |