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This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.
Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DR-1021 | Experimental | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
|
| Mircette | Active Comparator | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-1021 | Drug | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Estradiol Levels by Cycle Day | Levels of estradiol were measured throughout the study from blood samples. | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
| Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day | Levels of follicle stimulating hormone were measured throughout the study from blood samples. | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
| Serum Inhibin-B Levels by Cycle Day | Levels of inhibin-B were measured throughout the study from blood samples. | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Follicles Greater Than 5 mm in Diameter | Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point). | Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Lawrenceville | New Jersey | 08648 | United States | ||
| Duramed Investigational Site |
67 women were screened for participation in this study; 61 were enrolled and took at least 1 dose of their current regimen of oral contraceptive in Cycle 1 (the Run-in Cycle). Of the 61 enrolled, 3 participants discontinued the study prior to completing the Run-in Cycle and were therefore not randomly assigned to study drug in Cycle 2.
Female volunteers, aged 18-35 years old who were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) were enrolled at 4 investigative sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-In Cycle - All Enrolled | After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1. |
| FG001 | DR-1021 | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| FG002 | Mircette | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1: Run-in Cycle |
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| Cycle 2: Randomized Treatment Cycle |
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| Cycle 3: Follow-up |
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The Intent-to-treat (ITT) cohort consisted of all randomized participants who took at least one dose of randomized study medication and had at least one post-baseline efficacy measurement for at least one of the primary efficacy endpoints (FSH, inhibin-B, or estradiol).
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| ID | Title | Description |
|---|---|---|
| BG000 | DR-1021 | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Serum Estradiol Levels by Cycle Day | Levels of estradiol were measured throughout the study from blood samples. | Intent-to-treat population with available data at each time point (as indicated by n). | Posted | Median | Full Range | pg/mL | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
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From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
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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 | DR-1021 | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Teva Branded Pharmaceutical Products R&D | 610-786-7047 | clinicaltrialsdisclosure@tevapharm.com |
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| ID | Term |
|---|---|
| D017135 | Desogestrel |
| C034653 | Oviol |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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| Mircette® | Drug | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
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| Kariva® | Drug | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
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| Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size | The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound. | Cycle 2, Days 1-20 and Cycle 2, Days 21-28 |
| Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods | The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
| Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods | The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
| Number of Days of Bleeding During Unscheduled and Scheduled Study Periods | The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
| Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods | The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
| Columbus |
| Ohio |
| 43213 |
| United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Mircette | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Mircette | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
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| Secondary | Percentage of Follicles Greater Than 5 mm in Diameter | Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point). | Intent-to-treat | Posted | Number | percentage of follicles | Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4. |
|
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| Primary | Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day | Levels of follicle stimulating hormone were measured throughout the study from blood samples. | Intent-to-treat population with available data at each time point (as indicated by n). | Posted | Median | Full Range | mIU/mL | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
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| Primary | Serum Inhibin-B Levels by Cycle Day | Levels of inhibin-B were measured throughout the study from blood samples. | Intent-to-treat population with available data at each time point (as indicated by n). | Posted | Median | Full Range | pg/mL | Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6. |
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| Secondary | Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size | The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound. | Intent-to-treat population with available data. | Posted | Mean | Standard Deviation | mm | Cycle 2, Days 1-20 and Cycle 2, Days 21-28 |
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| Secondary | Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods | The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. | Intent-to-treat | Posted | Mean | Standard Deviation | days | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
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| Secondary | Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods | The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. | Intent-to-treat | Posted | Number | percentage of participants | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
|
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| Secondary | Number of Days of Bleeding During Unscheduled and Scheduled Study Periods | The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. | Intent-to-treat | Posted | Mean | Standard Deviation | days | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
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| Secondary | Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods | The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. | Intent-to-treat | Posted | Number | percentage of participants | Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21 |
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| 0 |
| 28 |
| 7 |
| 28 |
| EG001 | Mircette | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). | 1 | 28 | 7 | 28 |
| Upper respiratory tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Cycle 1 - Day 23 (n= 30, 76) |
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| Cycle 1 - Day 25 (n= 85, 106) |
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| Cycle 1 - Day 27 (n=135, 145) |
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| Cycle 2 - Day 4 (n=154, 156) |
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| Cycle 2 - Day 11 (n=76, 54) |
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| Cycle 2 - Days 19-20 (n=143, 148) |
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| Cycle 2 - Day 23 (n=91, 62) |
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| Cycle 2 - Day 25 (n=69, 80) |
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| Cycle 2 - Day 27 (n=94, 132) |
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| Cycle 3 - Day 4 (n=138, 117) |
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| Cycle 2 - Day 6 (n=28, 27) |
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| Cycle 2 - Days 19-20 (n=26, 28) |
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| Cycle 2 - Day 23 (n=27, 28) |
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| Cycle 2 - Day 24 (n=25, 28) |
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| Cycle 2 - Day 25 (n=27, 28) |
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| Cycle 2 - Day 27 (n=25, 28) |
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| Cycle 2 - Day 28 (n=26, 28) |
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| Cycle 3 - Day 2 (n=27, 28) |
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| Cycle 3 - Day 4 (n=27, 28) |
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| Cycle 3 - Day 6 (n=24, 26) |
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| Wilcoxon (Mann-Whitney) |
| 0.7678 |
| Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 6 time point. | Wilcoxon (Mann-Whitney) | 0.5782 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Days 19-20 time point. | Wilcoxon (Mann-Whitney) | 0.8083 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 23 time point. | Wilcoxon (Mann-Whitney) | 1.0000 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 24 time point. | Wilcoxon (Mann-Whitney) | 0.4122 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 25 time point. | Wilcoxon (Mann-Whitney) | 0.6675 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 27 time point. | Wilcoxon (Mann-Whitney) | 0.8445 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 28 time point. | Wilcoxon (Mann-Whitney) | 0.3772 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 2 time point. | Wilcoxon (Mann-Whitney) | 0.1918 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 4 time point. | Wilcoxon (Mann-Whitney) | 0.6675 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 6 time point. | Wilcoxon (Mann-Whitney) | 0.9226 | Superiority or Other (legacy) |
| Cycle 2 - Day 6 (n=28, 27) |
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| Cycle 2 - Days 19-20 (n=26, 28) |
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| Cycle 2 - Day 23 (n=27, 28) |
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| Cycle 2 - Day 24 (n=25, 28) |
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| Cycle 2 - Day 25 (n=27, 28) |
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| Cycle 2 - Day 27 (n=25, 28) |
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| Cycle 2 - Day 28 (n=26, 28) |
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| Cycle 3 - Day 2 (n=27, 28) |
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| Cycle 3 - Day 4 (n=27, 28) |
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| Cycle 3 - Day 6 (n=24, 26) |
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| Wilcoxon (Mann-Whitney) |
| 0.0629 |
| Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 6 time point. | Wilcoxon (Mann-Whitney) | 0.8464 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Days 19-20 time point. | Wilcoxon (Mann-Whitney) | 0.6316 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 23 time point. | Wilcoxon (Mann-Whitney) | 0.3000 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 24 time point. | Wilcoxon (Mann-Whitney) | 0.0955 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 25 time point. | Wilcoxon (Mann-Whitney) | 0.1523 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 2 - Day 27 time point. | Wilcoxon (Mann-Whitney) | 0.2809 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 28 time point. | Wilcoxon (Mann-Whitney) | 0.8829 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 2 time point. | Wilcoxon (Mann-Whitney) | 0.9262 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 -Day 4 time point. | Wilcoxon (Mann-Whitney) | 0.7811 | Superiority or Other (legacy) |
| Comparison of treatment groups at Cycle 3 - Day 6 time point. | Wilcoxon (Mann-Whitney) | 0.3703 | Superiority or Other (legacy) |
| Cycle 3 - Unscheduled (Day 1-21) |
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| Cycle 3 - Unscheduled (Day 1-21) |
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| Cycle 3 - Unscheduled (Day 1-21) |
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| Cycle 3 - Unscheduled (Day 1-21) |
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