Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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; medically important events. AEs included both serious and all non-serious adverse events. |
Baseline up to a maximum of 12 months |
|
| Primary |
Number of Participants Discontinued From Study Due to AEs |
Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
Baseline up to a maximum of 12 months |
|
| Primary |
Number of Participants Used Concomitant Medications for Treating AEs |
Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported. |
Baseline up to a maximum of 12 months |
|
| Primary |
Number of Participants With Clinically Significant Laboratory Test Abnormalities |
Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results. |
Baseline up to a maximum of 12 months |
|
| Primary |
Percentage of Participants Who Became Pregnant Over Observation Period |
The cumulative percent of participants who became pregnant over observation period was calculated as 100*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy. |
Baseline up to 12 months |
|
| Primary |
Rate of Pregnancies Per 100 Participant-years of Follow-up |
Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set. |
Baseline up to 12 months |
|
| Primary |
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug |
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure. |
Baseline, Month 3 |
|
| Primary |
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug |
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure. |
Baseline, Month 6 |
|
| Primary |
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug |
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure. |
Baseline, Month 9 |
|
| Primary |
Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug |
Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure. |
Baseline, Month 12 |
|
