Trial Outcomes & Findings for Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study (NCT NCT00528112)
NCT ID: NCT00528112
Last Updated: 2017-01-25
Results Overview
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2885 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2017-01-25
Participant Flow
Participant milestones
| Measure |
LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
|
|---|---|---|
|
Treatment up to 3 Years
STARTED
|
1432
|
1453
|
|
Treatment up to 3 Years
Participants Received Treatment
|
1432
|
1452
|
|
Treatment up to 3 Years
COMPLETED
|
819
|
870
|
|
Treatment up to 3 Years
NOT COMPLETED
|
613
|
583
|
|
Extension Phase
STARTED
|
0
|
707
|
|
Extension Phase
COMPLETED
|
0
|
550
|
|
Extension Phase
NOT COMPLETED
|
0
|
157
|
Reasons for withdrawal
| Measure |
LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
|
|---|---|---|
|
Treatment up to 3 Years
Adverse Event
|
313
|
278
|
|
Treatment up to 3 Years
Withdrawal by Subject
|
26
|
31
|
|
Treatment up to 3 Years
Protocol Violation
|
16
|
16
|
|
Treatment up to 3 Years
Death
|
0
|
1
|
|
Treatment up to 3 Years
Lost to Follow-up
|
63
|
61
|
|
Treatment up to 3 Years
Pregnancy
|
9
|
10
|
|
Treatment up to 3 Years
Other reasons
|
186
|
186
|
|
Extension Phase
Withdrawal by Subject
|
0
|
3
|
|
Extension Phase
Other reasons
|
0
|
100
|
|
Extension Phase
Pregnancy
|
0
|
3
|
|
Extension Phase
Lost to Follow-up
|
0
|
12
|
|
Extension Phase
Death
|
0
|
1
|
|
Extension Phase
Adverse Event
|
0
|
36
|
|
Extension Phase
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Baseline characteristics by cohort
| Measure |
LCS12
n=1432 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1452 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
Total
n=2884 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.2 Years
n=5 Participants
|
27.1 Years
n=7 Participants
|
27.1 Years
n=5 Participants
|
|
Age, Customized
≤ 25 years
|
566 Participants
n=5 Participants
|
564 Participants
n=7 Participants
|
1130 Participants
n=5 Participants
|
|
Age, Customized
> 25 years ≤ 35 years
|
866 Participants
n=5 Participants
|
888 Participants
n=7 Participants
|
1754 Participants
n=5 Participants
|
|
Gender
Female
|
1432 Participants
n=5 Participants
|
1452 Participants
n=7 Participants
|
2884 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Full analysis set
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
Outcome measures
| Measure |
LCS12
n=1432 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1452 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Pearl Index up to 3 Years
|
0.33 Pregnancies per 100 women years
Interval 0.16 to 0.6
|
0.31 Pregnancies per 100 women years
Interval 0.15 to 0.57
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Full analysis set
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Outcome measures
| Measure |
LCS12
n=1452 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Pearl Index for LCS16 up to 5 Years
|
0.29 Pregnancies per 100 women years
Interval 0.16 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 90Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1322 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1348 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Number of bleeding/spotting days
|
40.9 Days
Standard Deviation 19.1
|
39.7 Days
Standard Deviation 19.2
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Number of bleeding days
|
18.3 Days
Standard Deviation 12.3
|
17.7 Days
Standard Deviation 13.2
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Number of spotting only days
|
22.6 Days
Standard Deviation 14.1
|
21.9 Days
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Day 91 to Day 180Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1262 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1300 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Number of bleeding/spotting days
|
23.3 Days
Standard Deviation 14.8
|
21.1 Days
Standard Deviation 15.1
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Number of bleeding days
|
10.2 Days
Standard Deviation 8.7
|
8.7 Days
Standard Deviation 9.1
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Number of spotting only days
|
13.2 Days
Standard Deviation 10.4
|
12.3 Days
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Day 181 to Day 270Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1192 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1238 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Number of bleeding/spotting days
|
19.4 Days
Standard Deviation 13.2
|
16.3 Days
Standard Deviation 12.8
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Number of bleeding days
|
8.3 Days
Standard Deviation 8.2
|
6.3 Days
Standard Deviation 7.5
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Number of spotting only days
|
11.2 Days
Standard Deviation 9.0
|
10.0 Days
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Day 271 to Day 360Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1123 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1175 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Number of bleeding/spotting days
|
17.6 Days
Standard Deviation 12.1
|
14.3 Days
Standard Deviation 11.8
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Number of bleeding days
|
7.2 Days
Standard Deviation 7.2
|
5.1 Days
Standard Deviation 6.6
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Number of spotting only days
|
10.4 Days
Standard Deviation 8.3
|
9.1 Days
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Day 991 to Day 1080Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=770 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=819 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Number of bleeding/spotting days
|
13.4 Days
Standard Deviation 9.9
|
10.2 Days
Standard Deviation 9.5
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Number of bleeding days
|
4.8 Days
Standard Deviation 5.9
|
3.3 Days
Standard Deviation 5.3
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Number of spotting only days
|
8.6 Days
Standard Deviation 7.1
|
6.9 Days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1355 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1376 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Number of bleeding/spotting days
|
18.0 Days
Standard Deviation 8.0
|
17.3 Days
Standard Deviation 8.0
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Number of bleeding days
|
8.2 Days
Standard Deviation 6.0
|
8.1 Days
Standard Deviation 6.3
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Number of spotting only days
|
9.7 Days
Standard Deviation 6.5
|
9.2 Days
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Day 31 to Day 60Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1345 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1375 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Number of bleeding/spotting days
|
12.7 Days
Standard Deviation 7.6
|
12.9 Days
Standard Deviation 8.0
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Number of bleeding days
|
5.6 Days
Standard Deviation 4.9
|
5.5 Days
Standard Deviation 5.3
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Number of spotting only days
|
7.1 Days
Standard Deviation 5.9
|
7.3 Days
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Day 61 to Day 90Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1328 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1355 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Number of bleeding/spotting days
|
10.3 Days
Standard Deviation 6.9
|
9.5 Days
Standard Deviation 7.0
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Number of bleeding days
|
4.4 Days
Standard Deviation 4.1
|
4.1 Days
Standard Deviation 4.5
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Number of spotting only days
|
5.8 Days
Standard Deviation 5.2
|
5.4 Days
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Day 91 to Day 120Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1300 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1334 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Number of bleeding/spotting days
|
8.6 Days
Standard Deviation 6.0
|
7.8 Days
Standard Deviation 6.2
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Number of bleeding days
|
3.7 Days
Standard Deviation 3.6
|
3.2 Days
Standard Deviation 3.6
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Number of spotting only days
|
4.9 Days
Standard Deviation 4.5
|
4.6 Days
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Day 331 to Day 360Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=1130 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1186 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Number of bleeding/spotting days
|
5.7 Days
Standard Deviation 4.7
|
4.6 Days
Standard Deviation 4.4
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Number of bleeding days
|
2.3 Days
Standard Deviation 2.8
|
1.6 Days
Standard Deviation 2.5
|
|
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Number of spotting only days
|
3.4 Days
Standard Deviation 3.4
|
3.0 Days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 1Population: A subset of women from the full analysis set
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
Outcome measures
| Measure |
LCS12
n=14 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=12 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Number of Participants With/Without Ovulation - Year 1
With ovulation
|
13 Participants
|
11 Participants
|
|
Number of Participants With/Without Ovulation - Year 1
Without ovulation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 2Population: A subset of women from the full analysis set
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
Outcome measures
| Measure |
LCS12
n=11 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=10 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Number of Participants With/Without Ovulation - Year 2
With ovulation
|
10 Participants
|
9 Participants
|
|
Number of Participants With/Without Ovulation - Year 2
Without ovulation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 3Population: A subset of women from the full analysis set
Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.
Outcome measures
| Measure |
LCS12
n=11 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=7 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Number of Participants With/Without Ovulation - Year 3
With ovulation
|
11 Participants
|
7 Participants
|
|
Number of Participants With/Without Ovulation - Year 3
Without ovulation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 1Population: A subset of women from the full analysis set
Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
Outcome measures
| Measure |
LCS12
n=14 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=12 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Average Total Cervical Score - Year 1
|
3.067 Scores on a scale
Standard Deviation 1.291
|
3.127 Scores on a scale
Standard Deviation 1.620
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 2Population: A subset of women from the full analysis set
Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
Outcome measures
| Measure |
LCS12
n=11 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=10 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Average Total Cervical Score - Year 2
|
3.358 Scores on a scale
Standard Deviation 1.272
|
2.798 Scores on a scale
Standard Deviation 1.499
|
SECONDARY outcome
Timeframe: For six weeks in the second half of Year 3Population: A subset of women from the full analysis set
Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)
Outcome measures
| Measure |
LCS12
n=10 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=6 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Average Total Cervical Score - Year 3
|
2.837 Scores on a scale
Standard Deviation 1.354
|
2.448 Scores on a scale
Standard Deviation 1.521
|
SECONDARY outcome
Timeframe: At Year 1Population: A subset of women from the full analysis set
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Outcome measures
| Measure |
LCS12
n=26 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=23 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Classification of Endometrium - Year 1
Atrophic/inactive
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 1
Proliferative
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 1
Secretory
|
25 Participants
|
22 Participants
|
|
Classification of Endometrium - Year 1
Menstrual
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 1
Unclassified
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Year 2Population: A subset of women from the full analysis set
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Outcome measures
| Measure |
LCS12
n=22 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=19 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Classification of Endometrium - Year 2
Secretory
|
19 Participants
|
19 Participants
|
|
Classification of Endometrium - Year 2
Atrophic/inactive
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 2
Proliferative
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 2
Menstrual
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 2
Unclassified
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Year 3 / End of studyPopulation: A subset of women from the full analysis set
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Outcome measures
| Measure |
LCS12
n=25 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=23 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Classification of Endometrium - Year 3 / End of Study
Menstrual
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 3 / End of Study
Atrophic/inactive
|
0 Participants
|
0 Participants
|
|
Classification of Endometrium - Year 3 / End of Study
Proliferative
|
0 Participants
|
1 Participants
|
|
Classification of Endometrium - Year 3 / End of Study
Secretory
|
24 Participants
|
22 Participants
|
|
Classification of Endometrium - Year 3 / End of Study
Unclassified
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the end of study/Year 3Population: All participants from the full analysis set who had an assessment for this evaluation
Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
Outcome measures
| Measure |
LCS12
n=1053 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1063 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Degree of User Overall Satisfaction With Study Treatment
Missing
|
1 Participants
|
1 Participants
|
|
Degree of User Overall Satisfaction With Study Treatment
Very satisfied
|
796 Participants
|
842 Participants
|
|
Degree of User Overall Satisfaction With Study Treatment
Somewhat satisfied
|
201 Participants
|
177 Participants
|
|
Degree of User Overall Satisfaction With Study Treatment
Neither satisfied / dissatisfied
|
31 Participants
|
22 Participants
|
|
Degree of User Overall Satisfaction With Study Treatment
Dissatisfied
|
23 Participants
|
18 Participants
|
|
Degree of User Overall Satisfaction With Study Treatment
Very dissatisfied
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All participants from the full analysis set who had an assessment for this evaluation
If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
Outcome measures
| Measure |
LCS12
n=1426 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
n=1445 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Number of Participants With Partial or Total Expulsion
IUS partially expelled
|
24 Participants
|
30 Participants
|
|
Number of Participants With Partial or Total Expulsion
IUS totally expelled
|
29 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 1081 to Day 1170Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=617 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Number of bleeding/spotting days
|
9.6 Days
Standard Deviation 9.0
|
—
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Number of bleeding days
|
3.1 Days
Standard Deviation 4.8
|
—
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Number of spotting only days
|
6.6 Days
Standard Deviation 6.4
|
—
|
SECONDARY outcome
Timeframe: Day 1711 to Day 1800Population: All participants from the full analysis set who had an assessment for this evaluation
The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.
Outcome measures
| Measure |
LCS12
n=531 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Number of bleeding/spotting days
|
9.3 Days
Standard Deviation 8.8
|
—
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Number of bleeding days
|
2.9 Days
Standard Deviation 4.9
|
—
|
|
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Number of spotting only days
|
6.4 Days
Standard Deviation 6.1
|
—
|
SECONDARY outcome
Timeframe: At the end of study/Year 5Population: All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation
Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.
Outcome measures
| Measure |
LCS12
n=686 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Very satisfied
|
610 Participants
|
—
|
|
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Somewhat satisfied
|
70 Participants
|
—
|
|
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Neither satisfied / dissatisfied
|
3 Participants
|
—
|
|
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Dissatisfied
|
1 Participants
|
—
|
|
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Very dissatisfied
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants from the full analysis set who had an assessment for this evaluation
If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.
Outcome measures
| Measure |
LCS12
n=1445 Participants
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
|
LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
|
|---|---|---|
|
Number of Participants With Partial or Total Expulsion up to 5 Years
IUS partially expelled
|
35 Participants
|
—
|
|
Number of Participants With Partial or Total Expulsion up to 5 Years
IUS totally expelled
|
19 Participants
|
—
|
Adverse Events
LCS12, up to 3 Years
Serious events: 66 serious events
Other events: 952 other events
Deaths: 0 deaths
LCS16, up to 3 Years
Serious events: 72 serious events
Other events: 1014 other events
Deaths: 0 deaths
LCS16, up to 5 Years
Serious events: 86 serious events
Other events: 1054 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCS12, up to 3 Years
n=1432 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16, up to 3 Years
n=1452 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16, up to 5 Years
n=1452 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
|
|---|---|---|---|
|
Infections and infestations
Tubo-ovarian abscess
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Enterocolitis infectious
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Blood and lymphatic system disorders
Spherocytic anaemia
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Endocrine disorders
Goitre
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Eye disorders
Iridocyclitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
4/1432 • From start of treatment until end of study, up to 5 years.
|
0.28%
4/1452 • From start of treatment until end of study, up to 5 years.
|
0.28%
4/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
General disorders
Chest pain
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
General disorders
Pyrexia
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
General disorders
Device dislocation
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Immune system disorders
Drug hypersensitivity
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Appendicitis
|
0.42%
6/1432 • From start of treatment until end of study, up to 5 years.
|
0.48%
7/1452 • From start of treatment until end of study, up to 5 years.
|
0.55%
8/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Cellulitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Cystitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Genital herpes
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Infection
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Influenza
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Meningitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.28%
4/1452 • From start of treatment until end of study, up to 5 years.
|
0.34%
5/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Peritoneal abscess
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Peritonitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Peritonsillar abscess
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Pneumonia
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Tonsillitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Vestibular neuronitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Streptococcal sepsis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Herpes dermatitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Investigations
Weight increased
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma benign
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma, low grade
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Status migrainosus
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.21%
3/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.21%
3/1432 • From start of treatment until end of study, up to 5 years.
|
0.41%
6/1452 • From start of treatment until end of study, up to 5 years.
|
0.48%
7/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Depression
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.21%
3/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Depression suicidal
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Suicide attempt
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Polysubstance dependence
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Renal and urinary disorders
Strangury
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
0.14%
2/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.14%
2/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal perforation
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Surgical and medical procedures
Detoxification
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Vascular disorders
Hypertension
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.07%
1/1452 • From start of treatment until end of study, up to 5 years.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1432 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
0.00%
0/1452 • From start of treatment until end of study, up to 5 years.
|
Other adverse events
| Measure |
LCS12, up to 3 Years
n=1432 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16, up to 3 Years
n=1452 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
|
LCS16, up to 5 Years
n=1452 participants at risk
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
96/1432 • From start of treatment until end of study, up to 5 years.
|
6.7%
98/1452 • From start of treatment until end of study, up to 5 years.
|
7.0%
102/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.7%
67/1432 • From start of treatment until end of study, up to 5 years.
|
4.3%
62/1452 • From start of treatment until end of study, up to 5 years.
|
5.1%
74/1452 • From start of treatment until end of study, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
74/1432 • From start of treatment until end of study, up to 5 years.
|
4.0%
58/1452 • From start of treatment until end of study, up to 5 years.
|
4.1%
59/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Influenza
|
5.0%
72/1432 • From start of treatment until end of study, up to 5 years.
|
6.3%
92/1452 • From start of treatment until end of study, up to 5 years.
|
6.9%
100/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
103/1432 • From start of treatment until end of study, up to 5 years.
|
7.5%
109/1452 • From start of treatment until end of study, up to 5 years.
|
8.4%
122/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Sinusitis
|
6.3%
90/1432 • From start of treatment until end of study, up to 5 years.
|
6.6%
96/1452 • From start of treatment until end of study, up to 5 years.
|
7.4%
107/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
10.9%
156/1432 • From start of treatment until end of study, up to 5 years.
|
10.2%
148/1452 • From start of treatment until end of study, up to 5 years.
|
11.5%
167/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Vaginal infection
|
3.4%
48/1432 • From start of treatment until end of study, up to 5 years.
|
4.3%
62/1452 • From start of treatment until end of study, up to 5 years.
|
5.0%
73/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.0%
72/1432 • From start of treatment until end of study, up to 5 years.
|
5.1%
74/1452 • From start of treatment until end of study, up to 5 years.
|
5.9%
86/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Vaginitis bacterial
|
7.3%
105/1432 • From start of treatment until end of study, up to 5 years.
|
8.8%
128/1452 • From start of treatment until end of study, up to 5 years.
|
10.3%
150/1452 • From start of treatment until end of study, up to 5 years.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.9%
99/1432 • From start of treatment until end of study, up to 5 years.
|
7.4%
108/1452 • From start of treatment until end of study, up to 5 years.
|
8.7%
126/1452 • From start of treatment until end of study, up to 5 years.
|
|
Investigations
Weight increased
|
3.9%
56/1432 • From start of treatment until end of study, up to 5 years.
|
4.9%
71/1452 • From start of treatment until end of study, up to 5 years.
|
5.2%
76/1452 • From start of treatment until end of study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
59/1432 • From start of treatment until end of study, up to 5 years.
|
4.5%
65/1452 • From start of treatment until end of study, up to 5 years.
|
5.5%
80/1452 • From start of treatment until end of study, up to 5 years.
|
|
Nervous system disorders
Headache
|
9.2%
132/1432 • From start of treatment until end of study, up to 5 years.
|
9.4%
137/1452 • From start of treatment until end of study, up to 5 years.
|
10.1%
146/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
7.5%
107/1432 • From start of treatment until end of study, up to 5 years.
|
8.0%
116/1452 • From start of treatment until end of study, up to 5 years.
|
10.1%
147/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.1%
130/1432 • From start of treatment until end of study, up to 5 years.
|
7.5%
109/1452 • From start of treatment until end of study, up to 5 years.
|
8.0%
116/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
13.0%
186/1432 • From start of treatment until end of study, up to 5 years.
|
20.9%
303/1452 • From start of treatment until end of study, up to 5 years.
|
23.2%
337/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
96/1432 • From start of treatment until end of study, up to 5 years.
|
8.4%
122/1452 • From start of treatment until end of study, up to 5 years.
|
9.1%
132/1452 • From start of treatment until end of study, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.6%
66/1432 • From start of treatment until end of study, up to 5 years.
|
5.0%
73/1452 • From start of treatment until end of study, up to 5 years.
|
5.5%
80/1452 • From start of treatment until end of study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.4%
163/1432 • From start of treatment until end of study, up to 5 years.
|
11.7%
170/1452 • From start of treatment until end of study, up to 5 years.
|
12.3%
179/1452 • From start of treatment until end of study, up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators (PIs) have to send the publication to sponsor 90 days prior to planned publishing. The sponsor has maximum 60 days for review and for recommending changes or mark parts that have to be deleted from the publication due to harming sponsor's confidentiality rights. Sponsor can request a delay in publication release up to 6 months.
- Publication restrictions are in place
Restriction type: OTHER