Trial Outcomes & Findings for A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception (NCT NCT00995150)
NCT ID: NCT00995150
Last Updated: 2024-08-14
Results Overview
Number of pregnancies per year in each treatment arm.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1910 participants
Primary outcome timeframe
10 years
Results posted on
2024-08-14
Participant Flow
Enrollment into the Mirena arm was stopped when it was determined that sufficient comparative safety data for LILETTA vs. Mirena was already available; thereafter, subjects were only assigned to LILETTA. The data cutoff date of 05 April 2021 was chosen for all LILETTA subjects as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product). All Mirena participants were discontinued by the end of Year 5.
Participant milestones
| Measure |
LNG20 (16-35 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (16-35 years old)
|
Mirena
Levonorgestrel-releasing intrauterine system for contraception
Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Overall Study
STARTED
|
1600
|
159
|
151
|
|
Overall Study
COMPLETED
|
302
|
22
|
41
|
|
Overall Study
NOT COMPLETED
|
1298
|
137
|
110
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
4 participants' weights in the LNG20 (16-35 year olds) arm were not measured at baseline and therefore were not analyzed in the mean
Baseline characteristics by cohort
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (16-35 years old)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception
Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
Total
n=1910 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age 16-35 years
|
1,600 Participants
n=1600 Participants
|
159 Participants
n=159 Participants
|
0 Participants
n=151 Participants
|
1759 Participants
n=1910 Participants
|
|
Age, Customized
Age 36-45 years
|
0 Participants
n=1600 Participants
|
0 Participants
n=159 Participants
|
151 Participants
n=151 Participants
|
151 Participants
n=1910 Participants
|
|
Age, Customized
|
26.2 years
STANDARD_DEVIATION 4.4 • n=1600 Participants
|
26.1 years
STANDARD_DEVIATION 4.4 • n=159 Participants
|
39.6 years
STANDARD_DEVIATION 2.7 • n=151 Participants
|
27.2 years
STANDARD_DEVIATION 5.6 • n=1910 Participants
|
|
Sex: Female, Male
Female
|
1600 Participants
n=1600 Participants
|
159 Participants
n=159 Participants
|
151 Participants
n=151 Participants
|
1910 Participants
n=1910 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1600 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=1910 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
237 Participants
n=1600 Participants
|
21 Participants
n=159 Participants
|
21 Participants
n=151 Participants
|
279 Participants
n=1910 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1363 Participants
n=1600 Participants
|
138 Participants
n=159 Participants
|
130 Participants
n=151 Participants
|
1631 Participants
n=1910 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1600 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
19 Participants
n=1600 Participants
|
2 Participants
n=159 Participants
|
2 Participants
n=151 Participants
|
23 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
Asian
|
61 Participants
n=1600 Participants
|
5 Participants
n=159 Participants
|
7 Participants
n=151 Participants
|
73 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=1600 Participants
|
0 Participants
n=159 Participants
|
1 Participants
n=151 Participants
|
6 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
Black or African American
|
212 Participants
n=1600 Participants
|
12 Participants
n=159 Participants
|
20 Participants
n=151 Participants
|
244 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
White
|
1250 Participants
n=1600 Participants
|
131 Participants
n=159 Participants
|
120 Participants
n=151 Participants
|
1501 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
More than one race
|
49 Participants
n=1600 Participants
|
8 Participants
n=159 Participants
|
1 Participants
n=151 Participants
|
58 Participants
n=1910 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1600 Participants
|
1 Participants
n=159 Participants
|
0 Participants
n=151 Participants
|
5 Participants
n=1910 Participants
|
|
BMI
BMI ≤24.9
|
823 Participants
n=1600 Participants
|
68 Participants
n=159 Participants
|
59 Participants
n=151 Participants
|
950 Participants
n=1910 Participants
|
|
BMI
BMI 25-29.9
|
390 Participants
n=1600 Participants
|
52 Participants
n=159 Participants
|
37 Participants
n=151 Participants
|
479 Participants
n=1910 Participants
|
|
BMI
BMI 30-39.9
|
304 Participants
n=1600 Participants
|
28 Participants
n=159 Participants
|
41 Participants
n=151 Participants
|
373 Participants
n=1910 Participants
|
|
BMI
BMI ≥40
|
79 Participants
n=1600 Participants
|
11 Participants
n=159 Participants
|
14 Participants
n=151 Participants
|
104 Participants
n=1910 Participants
|
|
BMI
No Weight Taken at Baseline
|
4 Participants
n=1600 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=151 Participants
|
4 Participants
n=1910 Participants
|
|
Partner Status
Lives with Partner
|
915 Participants
n=1600 Participants
|
84 Participants
n=159 Participants
|
106 Participants
n=151 Participants
|
1105 Participants
n=1910 Participants
|
|
Partner Status
Does Not Live with Partner
|
685 Participants
n=1600 Participants
|
75 Participants
n=159 Participants
|
45 Participants
n=151 Participants
|
805 Participants
n=1910 Participants
|
|
Parity
Nulliparous
|
989 Participants
n=1600 Participants
|
90 Participants
n=159 Participants
|
22 Participants
n=151 Participants
|
1101 Participants
n=1910 Participants
|
|
Parity
Parous
|
611 Participants
n=1600 Participants
|
69 Participants
n=159 Participants
|
129 Participants
n=151 Participants
|
809 Participants
n=1910 Participants
|
|
BMI
|
26.8 (kg/m^2)
STANDARD_DEVIATION 6.7 • n=1596 Participants • 4 participants' weights in the LNG20 (16-35 year olds) arm were not measured at baseline and therefore were not analyzed in the mean
|
27.2 (kg/m^2)
STANDARD_DEVIATION 6.7 • n=159 Participants • 4 participants' weights in the LNG20 (16-35 year olds) arm were not measured at baseline and therefore were not analyzed in the mean
|
28.6 (kg/m^2)
STANDARD_DEVIATION 7.6 • n=151 Participants • 4 participants' weights in the LNG20 (16-35 year olds) arm were not measured at baseline and therefore were not analyzed in the mean
|
26.9 (kg/m^2)
STANDARD_DEVIATION 6.8 • n=1906 Participants • 4 participants' weights in the LNG20 (16-35 year olds) arm were not measured at baseline and therefore were not analyzed in the mean
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: All Mirena participants were discontinued by end of Year 5; therefore, Years 6-10 are considered "not available" for that arm.
Number of pregnancies per year in each treatment arm.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Number of Pregnancies Per Year
Year 1
|
2 pregnancies
|
1 pregnancies
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 2
|
4 pregnancies
|
0 pregnancies
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 3
|
1 pregnancies
|
0 pregnancies
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 4
|
1 pregnancies
|
0 pregnancies
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 5
|
1 pregnancies
|
1 pregnancies
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 6
|
0 pregnancies
|
NA pregnancies
All Mirena participants were discontinued by end of Year 5.
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 7
|
2 pregnancies
|
NA pregnancies
All Mirena participants were discontinued by end of Year 5.
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 8
|
0 pregnancies
|
NA pregnancies
All Mirena participants were discontinued by end of Year 5.
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 9
|
0 pregnancies
|
NA pregnancies
All Mirena participants were discontinued by end of Year 5.
|
0 pregnancies
|
|
Number of Pregnancies Per Year
Year 10
|
0 pregnancies
|
NA pregnancies
All Mirena participants were discontinued by end of Year 5.
|
0 pregnancies
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: The Pearl Index for MIRENA was not a pre-specified primary outcome measure and is therefore not included. The number of participants analyzed for this measure is the MITT population.
The Pearl Index (PI) is an estimate of the number of pregnancies per 100 women-years of contraceptive exposure. The Pearl Index is calculated as the number of "on treatment" pregnancies in the study divided by the total number of complete 28-day cycles of use in the study multiplied by 1,300 (13 cycles/yr x 100 years). Cycles where other birth control methods were used were excluded from this measure. The Pearl Index for MIRENA was not a pre-specified primary outcome measure and is therefore not included. There is only 8 years of data due to the early termination of the study.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1538 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=146 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Cumulative Pearl Index
Year 1
|
0.15 pregnancies per 100 women-years
Interval 0.02 to 0.55
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 2.83
|
—
|
|
Cumulative Pearl Index
Year 2
|
0.25 pregnancies per 100 women-years
Interval 0.09 to 0.54
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 1.49
|
—
|
|
Cumulative Pearl Index
Year 3
|
0.21 pregnancies per 100 women-years
Interval 0.08 to 0.43
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 1.04
|
—
|
|
Cumulative Pearl Index
Year 4
|
0.20 pregnancies per 100 women-years
Interval 0.08 to 0.39
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 0.81
|
—
|
|
Cumulative Pearl Index
Year 5
|
0.19 pregnancies per 100 women-years
Interval 0.09 to 0.36
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 0.67
|
—
|
|
Cumulative Pearl Index
Year 6
|
0.17 pregnancies per 100 women-years
Interval 0.08 to 0.33
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 0.59
|
—
|
|
Cumulative Pearl Index
Year 7
|
0.19 pregnancies per 100 women-years
Interval 0.1 to 0.35
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 0.52
|
—
|
|
Cumulative Pearl Index
Year 8
|
0.19 pregnancies per 100 women-years
Interval 0.09 to 0.33
|
0.0 pregnancies per 100 women-years
Interval 0.0 to 0.48
|
—
|
SECONDARY outcome
Timeframe: 10 YearsPopulation: All Mirena participants were discontinued by end of Year 5.
The safety and tolerability based on the report of adverse events and serious adverse events
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Safety and Tolerability
Subjects Reporting at Least One AE
|
1441 Participants
|
138 Participants
|
137 Participants
|
|
Safety and Tolerability
Subjects Reporting at Least One SAE
|
79 Participants
|
6 Participants
|
8 Participants
|
|
Safety and Tolerability
Subjects Reporting No AE or SAE
|
80 Participants
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 YearsPopulation: All Mirena participants were discontinued by end of Year 5.
The incidence of diary reported bleeding and/or spotting by 90-day interval, as an assessment of IUS-induced amenorrhea, is summarized as the number of subjects reporting no bleeding and/or spotting.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 1 (Month 3)
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 2 (Month 6)
|
167 Participants
|
27 Participants
|
16 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 4 (Month 12)
|
250 Participants
|
26 Participants
|
19 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 8 (Month 24)
|
283 Participants
|
27 Participants
|
35 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 12 (Month 36)
|
319 Participants
|
21 Participants
|
40 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 16 (Month 48)
|
275 Participants
|
23 Participants
|
37 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 20 (Month 60)
|
249 Participants
|
16 Participants
|
35 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 24 (Month 72)
|
199 Participants
|
—
|
33 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 28 (Month 84)
|
157 Participants
|
—
|
33 Participants
|
|
Distribution of Bleeding Amenorrhea by 90 Day Interval
90 Day Interval 32 (Month 96)
|
115 Participants
|
—
|
28 Participants
|
SECONDARY outcome
Timeframe: 10 YearsPopulation: All Mirena participants were discontinued by the end of Year 5 per the study protocol. All LNG20 (36-45 Yr Old) participants were discontinued by the end of Year 8 per the study protocol. Month 6 is defined as 182 days of use, Year 1= 365 days, Year 2= 730 days, Year 3= 1095 days, Year 4= 1460 days, Year 5= 1825 days, Year 6= 2190 days, Year 7= 2555 days, Year 8= 2920 days, Year 9= 3285 days, and Year 10= 3650 days of product use.
The rate of continuation of usage over time.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Continuation Rates
Number of Subjects Continuing Year 6 Through Year 7
|
402 Participants
|
0 Participants
|
72 Participants
|
|
Continuation Rates
Number of Subjects Continuing Through Month 6
|
1420 Participants
|
131 Participants
|
133 Participants
|
|
Continuation Rates
Number of Subjects Continuing Month 6 Through Year 1
|
1275 Participants
|
118 Participants
|
125 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 1 Through Year 2
|
1034 Participants
|
86 Participants
|
114 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 2 Through Year 3
|
859 Participants
|
64 Participants
|
105 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 3 Through Year 4
|
720 Participants
|
49 Participants
|
98 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 4 Through Year 5
|
597 Participants
|
21 Participants
|
91 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 5 Through Year 6
|
498 Participants
|
0 Participants
|
77 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 7 Through Year 8
|
293 Participants
|
0 Participants
|
39 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 8 Through Year 9
|
83 Participants
|
0 Participants
|
0 Participants
|
|
Continuation Rates
Number of Subjects Continuing Year 9 Through Year 10
|
76 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Only those subjects who completed this evaluation are included.
Subjects who discontinued from the trial and who were not pregnant or did not start a hormonal contraceptive were followed to assess the return of menses after IUS removal. If after three months menses had not occurred, the subject was to be evaluated for the cause of their secondary amenorrhea and continued to be followed monthly until the diagnosis was established.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=664 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=49 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=48 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Return of Menses After Discontinuation
Number (%) of Subjects With Onset of Menses Post-IUS Removal
|
651 Participants
|
46 Participants
|
38 Participants
|
|
Return of Menses After Discontinuation
Month 1
|
492 Participants
|
37 Participants
|
22 Participants
|
|
Return of Menses After Discontinuation
Month 2
|
141 Participants
|
8 Participants
|
15 Participants
|
|
Return of Menses After Discontinuation
Month 3
|
15 Participants
|
1 Participants
|
0 Participants
|
|
Return of Menses After Discontinuation
Month 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Return of Menses After Discontinuation
Month 5
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Distribution of Pregnancies (Months Post-IUS Removal) \[N(%)\]
Subjects who discontinued from the trial and desired pregnancy were followed for up to 12 months to assess fertility after IUS removal.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=241 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=19 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=3 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Return to Fertility After Discontinuation
Total Number of Participants Pregnant
|
201 Participants
|
15 Participants
|
2 Participants
|
|
Return to Fertility After Discontinuation
Month 1
|
17 Participants
|
3 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 2
|
36 Participants
|
5 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 3
|
34 Participants
|
2 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 4
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 5
|
20 Participants
|
2 Participants
|
1 Participants
|
|
Return to Fertility After Discontinuation
Month 6
|
18 Participants
|
1 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 7
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 8
|
16 Participants
|
1 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 9
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 10
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Return to Fertility After Discontinuation
Month 11
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Return to Fertility After Discontinuation
Month 12
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Mean Plasma Levonorgestrel Concentrations (pg/mL) for All Subjects in the PK Substudy.
The Mean Plasma Pharmacokinetics of LNG in a Subset of Subjects through 60 Months of Use. "Non-obese" was defined as a BMI less than 30 kg/m\^2. "Obese" was defined as a BMI of 30 kg/m\^2 or higher.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=19 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=18 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=21 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Week 1
|
187.6 (pg/mL)
Standard Deviation 53.4
|
328.9 (pg/mL)
Standard Deviation 150
|
310 (pg/mL)
Standard Deviation 139.7
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Week 2
|
199.3 (pg/mL)
Standard Deviation 59
|
320.3 (pg/mL)
Standard Deviation 147.4
|
278.7 (pg/mL)
Standard Deviation 107
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 1
|
180.5 (pg/mL)
Standard Deviation 44.8
|
251 (pg/mL)
Standard Deviation 98.2
|
247.7 (pg/mL)
Standard Deviation 82.6
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 3
|
166.8 (pg/mL)
Standard Deviation 40.8
|
222.7 (pg/mL)
Standard Deviation 58.5
|
237.4 (pg/mL)
Standard Deviation 75
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 6
|
153.7 (pg/mL)
Standard Deviation 40
|
215.8 (pg/mL)
Standard Deviation 59
|
229.5 (pg/mL)
Standard Deviation 67.3
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 9
|
134.9 (pg/mL)
Standard Deviation 38.4
|
184.9 (pg/mL)
Standard Deviation 52.4
|
229.9 (pg/mL)
Standard Deviation 69.9
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 12
|
140.5 (pg/mL)
Standard Deviation 52.6
|
182.5 (pg/mL)
Standard Deviation 43.9
|
192.3 (pg/mL)
Standard Deviation 36.2
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 18
|
126.3 (pg/mL)
Standard Deviation 32.6
|
168.1 (pg/mL)
Standard Deviation 32.1
|
168.6 (pg/mL)
Standard Deviation 38.5
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 24
|
115.7 (pg/mL)
Standard Deviation 26.6
|
150.2 (pg/mL)
Standard Deviation 28.9
|
180.8 (pg/mL)
Standard Deviation 39.9
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 30
|
111.1 (pg/mL)
Standard Deviation 33.2
|
161.1 (pg/mL)
Standard Deviation 51.3
|
164.2 (pg/mL)
Standard Deviation 43.5
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 36
|
104 (pg/mL)
Standard Deviation 53.9
|
152.3 (pg/mL)
Standard Deviation 50.5
|
152.6 (pg/mL)
Standard Deviation 38.4
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 42
|
101.7 (pg/mL)
Standard Deviation 43.9
|
131 (pg/mL)
Standard Deviation 51
|
151.9 (pg/mL)
Standard Deviation 41.8
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 48
|
93.2 (pg/mL)
Standard Deviation 30.6
|
114.5 (pg/mL)
Standard Deviation 33.8
|
136.1 (pg/mL)
Standard Deviation 37.9
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 54
|
93.7 (pg/mL)
Standard Deviation 22.3
|
103.3 (pg/mL)
Standard Deviation 43.5
|
127.3 (pg/mL)
Standard Deviation 40.8
|
|
Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
Month 60
|
68.1 (pg/mL)
Standard Deviation 30.3
|
136.9 (pg/mL)
Standard Deviation 62.4
|
109.5 (pg/mL)
Standard Deviation 34.9
|
SECONDARY outcome
Timeframe: month 36 through 120Population: Plasma Levonorgestrel Concentrations for All Subjects Beginning at Month 36. All Mirena participants were discontinued by the end of Year 5.
The Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=810 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=62 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=104 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 36
|
129.879 Levonorgestrel Concentration (pg/mL)
Standard Deviation 49.793
|
141.175 Levonorgestrel Concentration (pg/mL)
Standard Deviation 60.438
|
152.693 Levonorgestrel Concentration (pg/mL)
Standard Deviation 76.452
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 42
|
117.907 Levonorgestrel Concentration (pg/mL)
Standard Deviation 46.533
|
142.036 Levonorgestrel Concentration (pg/mL)
Standard Deviation 73.278
|
155.518 Levonorgestrel Concentration (pg/mL)
Standard Deviation 96.174
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 48
|
110.109 Levonorgestrel Concentration (pg/mL)
Standard Deviation 47.046
|
136.894 Levonorgestrel Concentration (pg/mL)
Standard Deviation 97.898
|
141.066 Levonorgestrel Concentration (pg/mL)
Standard Deviation 73.341
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 54
|
105.095 Levonorgestrel Concentration (pg/mL)
Standard Deviation 43.37
|
113.836 Levonorgestrel Concentration (pg/mL)
Standard Deviation 40.715
|
140.576 Levonorgestrel Concentration (pg/mL)
Standard Deviation 81.446
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 60
|
97.721 Levonorgestrel Concentration (pg/mL)
Standard Deviation 38.819
|
111.676 Levonorgestrel Concentration (pg/mL)
Standard Deviation 49.42
|
118.826 Levonorgestrel Concentration (pg/mL)
Standard Deviation 55.593
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 66
|
94.284 Levonorgestrel Concentration (pg/mL)
Standard Deviation 34.73
|
—
|
102.41 Levonorgestrel Concentration (pg/mL)
Standard Deviation 43.507
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 72
|
89.805 Levonorgestrel Concentration (pg/mL)
Standard Deviation 42.318
|
—
|
98.542 Levonorgestrel Concentration (pg/mL)
Standard Deviation 47.527
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 78
|
87.897 Levonorgestrel Concentration (pg/mL)
Standard Deviation 32.714
|
—
|
84.353 Levonorgestrel Concentration (pg/mL)
Standard Deviation 39.021
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 84
|
91.179 Levonorgestrel Concentration (pg/mL)
Standard Deviation 38.381
|
—
|
87.673 Levonorgestrel Concentration (pg/mL)
Standard Deviation 37.769
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 90
|
84.206 Levonorgestrel Concentration (pg/mL)
Standard Deviation 31.74
|
—
|
97.65 Levonorgestrel Concentration (pg/mL)
Standard Deviation 38.203
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 96
|
83.425 Levonorgestrel Concentration (pg/mL)
Standard Deviation 34.159
|
—
|
98.767 Levonorgestrel Concentration (pg/mL)
Standard Deviation 39.647
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 108
|
79.499 Levonorgestrel Concentration (pg/mL)
Standard Deviation 36.386
|
—
|
—
|
|
Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
Month 120
|
88.308 Levonorgestrel Concentration (pg/mL)
Standard Deviation 41.251
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 YearsPopulation: Endometrial thickness (ET) was evaluated in 52 LILETTA Efficacy Group subjects in the LNG20 (16-35 Yr Olds) arm only, with data both at Baseline and Month 12 (ET population) as part of a substudy conducted within the main protocol.
The Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=52 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years
Baseline
|
4.0 Endometrial Thickness (mm)
Standard Deviation 2.4
|
—
|
—
|
|
Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years
Month 12
|
3.8 Endometrial Thickness (mm)
Standard Deviation 1.8
|
—
|
—
|
|
Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years
Month 60
|
3.1 Endometrial Thickness (mm)
Standard Deviation 1.5
|
—
|
—
|
|
Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years
Month 120
|
2.6 Endometrial Thickness (mm)
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 YearsPopulation: In this substudy, a sampling of removed or expelled LNG20 IUSs were evaluated for residual drug content from Day 1 through Year 8. The total number of IUSs analyzed was 130 units from a total of 130 participants. All IUSs came from participants in the LNG20 (16-35 Yr Olds) arm. IUSs from participants in the Mirena arm were not evaluated in this substudy.
Analysis of residual LNG content from an appropriate sampling of IUSs that were removed or expelled during the study was to be summarized and plotted as a function of time of removal/expulsion. Residual drug content analysis was performed on a sampling of removed or expelled samples to determine the average in vivo drug release rate during the time the samples were implanted. All available samples were sorted and grouped by duration of use in 90-day intervals. The drug content and time of exposure of the samples analyzed were fit by an exponential regression to calculate the initial and average in vivo release rate over the duration of the study. NOTE: Year = 360 day intervals
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=130 IUS
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 1
|
45.1 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 2
|
39.1 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 3
|
33.8 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 4
|
29.3 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 5
|
25.4 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 6
|
22.0 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 7
|
19.1 mg/day
Standard Deviation 1.8
|
—
|
—
|
|
Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
Year 8
|
16.6 mg/day
Standard Deviation 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 YearsPopulation: Any incidences of bleeding and/or spotting were self-reported via daily diary log by remaining participants at regular intervals throughout the length of the study. All Mirena participants were discontinued by the end of Year 5.
From data based on the daily diary log, number of IUS subjects experiencing some bleeding and/or spotting.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1545 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=151 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=146 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Incidence of Bleeding and/or Spotting
Cycle 1 (Days 0- 28)
|
1536 Participants
|
150 Participants
|
145 Participants
|
|
Incidence of Bleeding and/or Spotting
Cycle 2 (Days 29 - 57)
|
1394 Participants
|
131 Participants
|
139 Participants
|
|
Incidence of Bleeding and/or Spotting
Cycle 3 (Days 58 - 86)
|
1276 Participants
|
122 Participants
|
122 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 1
|
1070 Participants
|
97 Participants
|
109 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 2
|
779 Participants
|
54 Participants
|
79 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 3
|
557 Participants
|
44 Participants
|
65 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 4
|
468 Participants
|
28 Participants
|
60 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 5
|
369 Participants
|
22 Participants
|
54 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 6
|
310 Participants
|
—
|
45 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 7
|
260 Participants
|
—
|
39 Participants
|
|
Incidence of Bleeding and/or Spotting
Year 8
|
189 Participants
|
—
|
33 Participants
|
SECONDARY outcome
Timeframe: 8 yearsPopulation: Note: a year is considered 364 days (13 women-months). Only the efficacy population (LNG20 16-35 years old) was evaluated, per protocol.
Life table methods were used to estimate the cumulative pregnancy rate after each year. Confirmed pregnancy was the failure outcome and the corresponding time to pregnancy was the failure time. Time to pregnancy was calculated as the date a confirmed pregnancy was initially reported minus the date of IUS placement plus one.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1545 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Cumulative Pregnancy Rates
Year 1
|
0.14 number of pregnancies per year
Interval 0.04 to 0.57
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 2
|
0.49 number of pregnancies per year
Interval 0.22 to 1.09
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 3
|
0.59 number of pregnancies per year
Interval 0.28 to 1.25
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 4
|
0.72 number of pregnancies per year
Interval 0.36 to 1.45
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 5
|
0.87 number of pregnancies per year
Interval 0.44 to 1.7
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 6
|
0.87 number of pregnancies per year
Interval 0.44 to 1.7
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 7
|
1.30 number of pregnancies per year
Interval 0.69 to 2.47
|
—
|
—
|
|
Cumulative Pregnancy Rates
Year 8
|
1.30 number of pregnancies per year
Interval 0.69 to 2.47
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: All Mirena participants were discontinued by end of Year 5 per the study protocol. All LNG20 (36-45 Yr Old) participants were discontinued by end of Year 8 per the study protocol.
The expulsion rate includes the number of subjects with reported expulsions or removal of the IUS, regardless of reason.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Expulsion Rate
IUS Placement through Year 1
|
47 Participants
|
8 Participants
|
3 Participants
|
|
Expulsion Rate
Year 1 through Year 2
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Expulsion Rate
Year 2 through Year 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Expulsion Rate
Year 3 through Year 4
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Expulsion Rate
Year 4 through Year 5
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Expulsion Rate
Year 5 through Year 6
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Expulsion Rate
Year 6 through Year 7
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Expulsion Rate
Year 7 through Year 8
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Expulsion Rate
Year 8 through Year 9
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Expulsion Rate
Year 9 through Year 10
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: No standard deviation since there was only one Mirena participant measured at month 120
Measuring the change in hemoglobin results from the screening visit and following 12 months, 60 months and 120 months of product use.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Change in Hemoglobin Values
Change from Screening to Month 12
|
0.2 g/dL
Standard Deviation 0.9
|
0.2 g/dL
Standard Deviation 1.1
|
0.1 g/dL
Standard Deviation 0.8
|
|
Change in Hemoglobin Values
Change from Screening to Month 60
|
0.3 g/dL
Standard Deviation 1.0
|
0.1 g/dL
Standard Deviation 1.1
|
0.3 g/dL
Standard Deviation 0.8
|
|
Change in Hemoglobin Values
Change from Screening to Month 120
|
0.3 g/dL
Standard Deviation 1.0
|
-0.7 g/dL
Standard Deviation NA
No standard deviation since there was only one Mirena participant measured at month 120
|
0.3 g/dL
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: All Mirena participants were discontinued by end of Year 5 per the study protocol. All LNG20 (36-45 Yr Old) participants were discontinued by Year 8 per the study protocol.
Time to event was calculated as the date of continuation/expulsion/removal minus the date of IUS placement plus one. Subjects without a continuation/expulsion/removal were censored at the last contact date and failure time was calculated as the last contact date minus the date of IUS placement plus one.
Outcome measures
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 Participants
LNG20 levonorgestrel-releasing intrauterine system
LNG20: levonorgestrel-releasing intrauterine system for contraception (16-35 Yr Olds)
|
Mirena
n=159 Participants
Levonorgestrel-releasing intrauterine system for contraception Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 Participants
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Discontinuation for Safety Reasons
Year 1
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 8
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 9
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Discontinuation for Safety Reasons
Year 10
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
LNG20 (16-35 Yr Olds)
Serious events: 78 serious events
Other events: 1441 other events
Deaths: 1 deaths
Mirena
Serious events: 6 serious events
Other events: 138 other events
Deaths: 0 deaths
LNG20 (36-45 Yr Olds)
Serious events: 8 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 participants at risk
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (16-35 years old)
|
Mirena
n=159 participants at risk
Levonorgestrel-releasing intrauterine system for contraception
Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 participants at risk
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Congenital, familial and genetic disorders
Hamartoma
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
67/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.1%
5/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
4.6%
7/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.19%
3/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
31/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.1%
5/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Enteritis
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Catheter related complication
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Non-cardiac chest pain
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
4/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
7/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.5%
4/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Immune system disorders
Anaphylactic reaction
|
0.19%
3/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Appendicitis
|
0.44%
7/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Appendix perforated
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Cellulitis
|
0.88%
14/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.0%
3/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Clostridial infection
|
0.31%
5/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Diverticulitis
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Herpes Simplex
|
1.1%
17/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.56%
9/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Postoperative abscess
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Respiratory tract infection
|
0.31%
5/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Tooth abscess
|
0.81%
13/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.3%
5/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
3/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.25%
4/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.1%
33/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.6%
4/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
46/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.1%
5/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.19%
3/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage IV
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Intracranial hypotension
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Multiple sclerosis
|
0.38%
6/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Nervous system disorder
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Syncope
|
1.4%
22/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.44%
7/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Affective disorder
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Bipolar disorder
|
0.94%
15/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.5%
4/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Completed suicide
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Drug abuse
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Mania
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Substance abuse
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Suicidal ideation
|
0.25%
4/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Suicide attempt
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.12%
2/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
14/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
4.0%
6/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Renal failure chronic
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
Renal vasculitis
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
4.6%
74/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.9%
3/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.56%
9/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Vaginal laceration
|
0.38%
6/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.66%
1/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Ovarian rupture
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Self-injurious ideation
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.69%
11/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.9%
3/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.6%
4/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.06%
1/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Gastritis
|
0.56%
9/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.3%
2/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
14/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.9%
3/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.0%
3/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.63%
1/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Other adverse events
| Measure |
LNG20 (16-35 Yr Olds)
n=1600 participants at risk
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (16-35 years old)
|
Mirena
n=159 participants at risk
Levonorgestrel-releasing intrauterine system for contraception
Mirena: Mirena intrauterine system
|
LNG20 (36-45 Yr Olds)
n=151 participants at risk
LNG20 levonorgestrel-releasing intrauterine system LNG20: levonorgestrel-releasing intrauterine system for contraception sub-population (36-45 years old)
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.9%
127/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.9%
11/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Bronchitis
|
6.4%
102/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
4.4%
7/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.6%
16/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Influenza
|
10.5%
168/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.7%
17/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.6%
13/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Nasopharyngitis
|
24.1%
386/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
17.0%
27/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
14.6%
22/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.6%
89/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
4.4%
7/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.6%
10/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Sinusitis
|
11.2%
179/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.7%
17/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.6%
16/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
191/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
11.3%
18/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.9%
24/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Urinary tract infection
|
17.9%
287/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.7%
25/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
17.9%
27/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Vaginitis bacterial
|
17.7%
283/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
14.5%
23/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
21.2%
32/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
17.9%
287/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
17.0%
27/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
11.3%
17/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Human papilloma virus test positive
|
5.5%
88/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.1%
5/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.0%
9/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
Weight increased
|
5.4%
87/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.3%
10/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.6%
19/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
98/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.8%
6/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
9.9%
15/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Headache
|
9.1%
145/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.2%
13/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
13.9%
21/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Anxiety
|
9.2%
148/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.8%
14/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
13.2%
20/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Depression
|
7.9%
126/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.3%
10/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Breast tenderness
|
7.7%
123/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.3%
10/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.6%
10/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
13.2%
212/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.9%
11/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
11.9%
18/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.0%
128/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.0%
3/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Dyspareunia
|
7.8%
125/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.5%
4/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
2.0%
3/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
113/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.3%
10/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.3%
5/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.8%
93/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.7%
9/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
15.4%
247/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
12.6%
20/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
7.9%
12/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Immune system disorders
Seasonal allergy
|
4.0%
64/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
8/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
6.0%
9/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Insomnia
|
3.3%
53/1600 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.7%
9/159 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.3%
8/151 • 10 years
An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60