Trial Outcomes & Findings for A Study of Leuprolide to Treat Prostate Cancer (NCT NCT00626431)
NCT ID: NCT00626431
Last Updated: 2011-07-19
Results Overview
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
310 participants
Primary outcome timeframe
Week 4 to Week 48
Results posted on
2011-07-19
Participant Flow
The enrollment of subjects with Formulation A occurred sequentially before the enrollment of subjects with Formulation B.
Formulation A and Formulation B treatment groups were enrolled sequentially. All analyses and summaries were conducted separately for both treatment groups.
Participant milestones
| Measure |
Leuprolide Acetate - Formulation A
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
Leuprolide Acetate - Formulation B
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
159
|
|
Overall Study
COMPLETED
|
134
|
114
|
|
Overall Study
NOT COMPLETED
|
17
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Leuprolide to Treat Prostate Cancer
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate - Formulation A
n=151 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
Leuprolide Acetate - Formulation B
n=159 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
133 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=99 Participants
|
159 participants
n=107 Participants
|
310 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 4 to Week 48Population: The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (\>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=148 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.
|
93.6 Percent Suppressed
90% Confidence Interval 2.05 • Interval 90.2 to 97.0
|
PRIMARY outcome
Timeframe: Week 4 to Week 48The adjusted percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=148 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted
|
93.4 Percent Suppressed
Interval 89.9 to 96.9
|
PRIMARY outcome
Timeframe: Week 4 to Week 48Population: The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (\>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=154 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned
|
86.9 Percent suppressed
Interval 82.2 to 91.7
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final VisitPopulation: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=151 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Day 2
|
613.1 ng/dL
Standard Error 21.53
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 24
|
14.3 ng/dL
Standard Error 1.25
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 26
|
9.0 ng/dL
Standard Error 0.47
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 30
|
9.9 ng/dL
Standard Error 1.67
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 34
|
13.0 ng/dL
Standard Error 4.14
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 40
|
8.8 ng/dL
Standard Error 0.41
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 46
|
8.8 ng/dL
Standard Error 0.46
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 48/Final Visit
|
13.3 ng/dL
Standard Error 3.67
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Day 8
|
468.2 ng/dL
Standard Error 16.55
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 2
|
127.1 ng/dL
Standard Error 7.36
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 4
|
16.0 ng/dL
Standard Error 0.70
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 8
|
9.6 ng/dL
Standard Error 0.46
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 14
|
9.2 ng/dL
Standard Error 0.46
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at Week 20
|
8.5 ng/dL
Standard Error 0.46
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population
Testosterone concentration at baseline
|
432.9 ng/dL
Standard Error 14.35
|
SECONDARY outcome
Timeframe: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final VisitPopulation: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=157 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at baseline
|
414.0 ng/dL
Standard Error 14.15
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Day 2
|
578.0 ng/dL
Standard Error 20.14
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Day 8
|
466.9 ng/dL
Standard Error 17.70
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 2
|
127.4 ng/dL
Standard Error 7.35
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 4
|
15.3 ng/dL
Standard Error 0.71
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 8
|
9.1 ng/dL
Standard Error 0.44
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 14
|
8.9 ng/dL
Standard Error 0.42
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 20
|
9.6 ng/dL
Standard Error 0.54
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 24
|
28.0 ng/dL
Standard Error 3.97
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 26
|
15.6 ng/dL
Standard Error 2.63
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 30
|
9.4 ng/dL
Standard Error 0.60
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 34
|
9.7 ng/dL
Standard Error 0.53
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 40
|
9.5 ng/dL
Standard Error 0.52
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 46
|
9.4 ng/dL
Standard Error 0.64
|
|
Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population
Testosterone concentration at Week 48/Final Visit
|
13.8 ng/dL
Standard Error 1.87
|
SECONDARY outcome
Timeframe: Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)Population: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=135 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 2 hours postdose
|
-1.9 ng/dL
Standard Error 0.85
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 4 hours postdose
|
-1.2 ng/dL
Standard Error 0.93
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 8 hours postdose
|
-1.3 ng/dL
Standard Error 1.02
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Day 1 postdose
|
-0.1 ng/dL
Standard Error 0.95
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Day 2 postdose
|
-0.1 ng/dL
Standard Error 0.92
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Days 3-10 postdose
|
-1.0 ng/dL
Standard Error 0.89
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Days 11-17 postdose
|
-2.1 ng/dL
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)Population: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=124 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 2 hours postdose
|
-0.7 ng/dL
Standard Error 0.66 • Interval -101.2 to 18.0
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 4 hours postdose
|
1.6 ng/dL
Standard Error 1.13 • Interval -99.3 to 34.0
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 8 hours postdose
|
3.6 ng/dL
Standard Error 1.35 • Interval -101.5 to 47.0
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Day 1 postdose
|
8.0 ng/dL
Standard Error 1.80 • Interval -99.8 to 46.0
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Day 2 postdose
|
7.8 ng/dL
Standard Error 1.81 • Interval -99.2 to 48.7
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Days 3-10 postdose
|
4.5 ng/dL
Standard Error 1.07 • Interval -96.7 to 44.7
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Day 11-17 postdose
|
-4.2 ng/dL
Standard Error 1.43 • Interval -97.5 to 13.0
|
SECONDARY outcome
Timeframe: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)Population: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=134 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 2 hours postdose
|
0.2 ng/dL
Standard Error 0.03
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 4 hours postdose
|
0.2 ng/dL
Standard Error 0.03
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at 8 hours postdose
|
0.2 ng/dL
Standard Error 0.02
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Day 1 postdose
|
0.2 ng/dL
Standard Error 0.02
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Day 2 postdose
|
0.1 ng/dL
Standard Error 0.01
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Days 3-10 postdose
|
0.1 ng/dL
Standard Error 0.01
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population
Testosterone concentration at Days 11-17 postdose
|
0.1 ng/dL
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)Population: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=123 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 2 hours postdose
|
0.4 ng/dL
Standard Error 0.07
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 4 hours postdose
|
0.5 ng/dL
Standard Error 0.12
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at 8 hours postdose
|
0.4 ng/dL
Standard Error 0.11
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Day 1 postdose
|
0.4 ng/dL
Standard Error 0.08
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Day 2 postdose
|
0.2 ng/dL
Standard Error 0.04
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Days 3-10 postdose
|
0.1 ng/dL
Standard Error 0.02
|
|
Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population
Testosterone concentration at Days 11-17 postdose
|
-0.1 ng/dL
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final VisitPopulation: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=151 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA concentration at baseline
|
35.0 ng/mL
Standard Error 11.21
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Day 8
|
40.4 ng/mL
Standard Error 12.90
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Week 14
|
2.4 ng/mL
Standard Error 0.62
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Week 24
|
2.9 ng/mL
Standard Error 1.09
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Week 30
|
1.6 ng/mL
Standard Error 0.46
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Week 40
|
2.2 ng/mL
Standard Error 0.82
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population
PSA Concentration at Week 48/Final Visit
|
3.7 ng/mL
Standard Error 1.51
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final VisitPopulation: The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.
PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.
Outcome measures
| Measure |
Leuprolide Acetate - Formulation A
n=157 Participants
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA concentration at baseline
|
20.5 ng/mL
Standard Error 3.88
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Day 8
|
23.1 ng/mL
Standard Error 4.03
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Week 14
|
2.4 ng/mL
Standard Error 0.51
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Week 24
|
2.5 ng/mL
Standard Error 0.65
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Week 30
|
2.7 ng/mL
Standard Error 0.86
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Week 40
|
2.5 ng/mL
Standard Error 0.85
|
|
Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population
PSA Concentration at Week 48/Final Visit
|
6.2 ng/mL
Standard Error 2.75
|
Adverse Events
Leuprolide Acetate - Formulation A
Serious events: 31 serious events
Other events: 133 other events
Deaths: 0 deaths
Leuprolide Acetate - Formulation B
Serious events: 41 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leuprolide Acetate - Formulation A
n=151 participants at risk
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
Leuprolide Acetate - Formulation B
n=159 participants at risk
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
acute coronary syndrome
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
angina pectoris
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
angina unstable
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
atrial fibrillation
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
atrioventricular block complete
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
atrioventricular block second degree
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
cardiac failure congestive
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.9%
3/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
coronary artery disease
|
2.0%
3/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.3%
2/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
sick sinus syndrome
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Blood and lymphatic system disorders
iron deficiency anemia
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
palpitations
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
colonic pseudo-obstruction
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
fecaloma
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
intestinal perforation
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
esophageal achalasia
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
pancreatitis acute
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
pneumatosis intestinalis
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
retroperitoneal hemorrhage
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
vomiting
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
asthenia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
chest pain
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
multi-organ failure
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Hepatobiliary disorders
cholecystitis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
acute sinusitis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
bronchiectasis
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
bronchitis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
cellulitis
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
enterobacter sepsis
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
lobar pneumonia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
pneumonia
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.9%
3/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
septic shock
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
urinary tract infection
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
urosepsis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
humerus fracture
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
lumbar vertebral fracture
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
in-stent coronary artery restenosis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
lung injury
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Metabolism and nutrition disorders
hypovolemia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Metabolism and nutrition disorders
diabetic ketacidosis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
rhabdomyolysis
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder cancer stage I, without cancer in situ
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder transitional cell carcinoma
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer stage II
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hepatic neoplasm malignant
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-Hodgkin's lymphoma stage IV
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-small cell lung cancer
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer metastatic
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
carotid artery stenosis
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
cerebrovascular accident
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.3%
2/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
cerebrovascular disorder
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
dementia
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
hemorrhagic transformation stroke
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
presyncope
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
spinal hematoma
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
syncope
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.9%
3/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
transient ischemic attack
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Psychiatric disorders
completed suicide
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
mental status change
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
hematuria
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
renal failure acute
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
ureteric obstruction
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
2.0%
3/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
hemothorax
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
pleural effusion
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.3%
2/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
1.3%
2/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
aortic aneurysm
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
hypotension
|
0.00%
0/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
orthostatic hypotension
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Hepatobiliary disorders
cholelithiasis
|
1.3%
2/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.66%
1/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.00%
0/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
Other adverse events
| Measure |
Leuprolide Acetate - Formulation A
n=151 participants at risk
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
Leuprolide Acetate - Formulation B
n=159 participants at risk
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
6/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
constipation
|
9.9%
15/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
10.1%
16/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Gastrointestinal disorders
nausea
|
3.3%
5/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.0%
8/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
fatigue
|
11.9%
18/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
8.8%
14/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
injection site pain
|
17.9%
27/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
16.4%
26/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
General disorders
edema peripheral
|
4.6%
7/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
nasopharyngitis
|
6.6%
10/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
9.4%
15/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
upper respiratory tract infection
|
5.3%
8/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Infections and infestations
urinary tract infection
|
4.6%
7/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.0%
8/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
8.6%
13/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
13.8%
22/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.3%
8/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.6%
7/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Psychiatric disorders
insomnia
|
8.6%
13/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
dizziness
|
5.3%
8/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
9.4%
15/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Nervous system disorders
headache
|
7.3%
11/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.7%
9/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
dysuria
|
6.0%
9/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.0%
8/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
hematuria
|
6.0%
9/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
0.63%
1/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Renal and urinary disorders
nocturia
|
5.3%
8/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
2.5%
4/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.6%
10/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
3.8%
6/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
4.0%
6/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
5.0%
8/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
hot flush
|
58.3%
88/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
44.7%
71/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Vascular disorders
hypertension
|
6.0%
9/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
9.4%
15/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
5.3%
8/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
3.8%
6/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
|
Skin and subcutaneous tissue disorders
rash
|
6.0%
9/151 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
3.8%
6/159 • Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
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Restriction type: OTHER