Trial Outcomes & Findings for Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects. (NCT NCT00877877)
NCT ID: NCT00877877
Last Updated: 2020-01-18
Results Overview
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
632 participants
Primary outcome timeframe
At Month 60
Results posted on
2020-01-18
Participant Flow
Subjects who participated in the primary study (NCT00196924) and received 3 doses of Cervarix.
Subjects enrolled in this study were primed with Cervarix vaccine as part of study NCT00196924. Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up phases. Actual enrollment differed depending on the rate of return for the follow-up study, so not all subjects enrolled came to each visit.
Participant milestones
| Measure |
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Year 5
STARTED
|
397
|
|
Year 5
COMPLETED
|
397
|
|
Year 5
NOT COMPLETED
|
0
|
|
Year 6
STARTED
|
529
|
|
Year 6
COMPLETED
|
529
|
|
Year 6
NOT COMPLETED
|
0
|
|
Year 7
STARTED
|
523
|
|
Year 7
COMPLETED
|
523
|
|
Year 7
NOT COMPLETED
|
0
|
|
Year 8
STARTED
|
522
|
|
Year 8
COMPLETED
|
522
|
|
Year 8
NOT COMPLETED
|
0
|
|
Year 9
STARTED
|
507
|
|
Year 9
COMPLETED
|
507
|
|
Year 9
NOT COMPLETED
|
0
|
|
Year 10
STARTED
|
495
|
|
Year 10
COMPLETED
|
495
|
|
Year 10
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=529 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Age, Continuous
Year 5
|
17.1 Years
STANDARD_DEVIATION 1.40 • n=99 Participants
|
|
Age, Continuous
Year 6
|
18.0 Years
STANDARD_DEVIATION 1.40 • n=99 Participants
|
|
Age, Continuous
Year 7
|
19.0 Years
STANDARD_DEVIATION 1.39 • n=99 Participants
|
|
Age, Continuous
Year 8
|
20.0 Years
STANDARD_DEVIATION 1.40 • n=99 Participants
|
|
Age, Continuous
Year 9
|
21.1 Years
STANDARD_DEVIATION 1.42 • n=99 Participants
|
|
Age, Continuous
Year 10
|
22.0 Years
STANDARD_DEVIATION 1.40 • n=99 Participants
|
|
Sex/Gender, Customized
Female
|
495 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
529 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Month 60Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=358 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-18 Month 60 [N=358]
|
358 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-16 Month 60 [N=353]
|
353 Subjects
|
PRIMARY outcome
Timeframe: At Month 72Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=478 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-16 Month 72 [N=475]
|
475 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-18 Month 72 [N=478]
|
478 Subjects
|
PRIMARY outcome
Timeframe: At Month 84Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=473 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
HPV-18 Month 84 [N=473]
|
473 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
HPV-16 Month 84 [N=469]
|
469 Subjects
|
PRIMARY outcome
Timeframe: At Month 96Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=477 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-16 Month 96 [N=473]
|
473 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
anti-HPV-18 Month 96 [N=477]
|
477 Subjects
|
PRIMARY outcome
Timeframe: At Month 60Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=376 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-16 Month 60 [N=376]
|
2262.9 EL.U/mL
Interval 2069.1 to 2475.0
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-18 Month 60 [N=376]
|
778.6 EL.U/mL
Interval 703.1 to 862.1
|
PRIMARY outcome
Timeframe: At month 72Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=502 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-16 Month 72 [N=502]
|
1973.9 EL.U/mL
Interval 1827.9 to 2131.6
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-18 Month 72 [N=502]
|
762.8 EL.U/mL
Interval 701.0 to 830.1
|
PRIMARY outcome
Timeframe: At Month 84Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=494 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-018 Month 84 [N=494]
|
609.7 EL.U/mL
Interval 559.0 to 664.9
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-016 Month 84 [N=494]
|
1756.7 EL.U/mL
Interval 1622.7 to 1901.7
|
PRIMARY outcome
Timeframe: At Month 96Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=499 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-16 Month 96 [N=499]
|
1671.0 EL.U/mL
Interval 1548.1 to 1803.7
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
anti-HPV-18 Month 96 [N=499]
|
679.0 EL.U/mL
Interval 623.5 to 739.4
|
PRIMARY outcome
Timeframe: At Month 108Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=374 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 Month 108 [N=374]
|
372 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-18 Month 108 [N=370]
|
368 Subjects
|
PRIMARY outcome
Timeframe: At Month 108Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=392 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 Month 108 [N=392]
|
1946.5 EL.U/ML
Interval 1779.7 to 2128.9
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-18 Month 108 [N=391]
|
754.0 EL.U/ML
Interval 685.4 to 829.4
|
PRIMARY outcome
Timeframe: At Month 120Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=416 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 Month 120 [N=416]
|
1607.9 EL.U/mL
Interval 1480.8 to 1746.1
|
|
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-18 Month 120 [N=415]
|
608 EL.U/mL
Interval 552.5 to 669.1
|
PRIMARY outcome
Timeframe: At Month 120Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=395 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 Month 120 [N=393]
|
393 Subjects
|
|
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-18 Month 120 [N=395]
|
395 Subjects
|
SECONDARY outcome
Timeframe: From Month 48 to Month 60Population: The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=397 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
9 Subjects
|
SECONDARY outcome
Timeframe: From Month 60 to Month 72Population: Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=529 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
20 Subjects
|
SECONDARY outcome
Timeframe: From Month 72 to Month 84Population: Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=523 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
20 Subjects
|
SECONDARY outcome
Timeframe: From Month 84 to Month 96SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=522 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
8 Subjects
|
SECONDARY outcome
Timeframe: From Month 96 to Month 108SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=507 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
15 Subjects
|
SECONDARY outcome
Timeframe: From Month 108 to Month 120SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=495 Participants
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
6 Subjects
|
Adverse Events
Cervarix Group From Month 48 Until Month 60
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Group From Month 60 Until Month 72
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Group From Month 72 to Month 84
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Group From Month 84 to Month 96
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Group From Month 96 to Month 108
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Group From Month 108 to Month 120
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group From Month 48 Until Month 60
n=397 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
|
Cervarix Group From Month 60 Until Month 72
n=529 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
|
Cervarix Group From Month 72 to Month 84
n=523 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
|
Cervarix Group From Month 84 to Month 96
n=522 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
|
Cervarix Group From Month 96 to Month 108
n=507 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
|
Cervarix Group From Month 108 to Month 120
n=495 participants at risk
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.57%
3/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Abscess
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Appendicitis
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Cystitis
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Congenital, familial and genetic disorders
Skull malformation
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.25%
1/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Endometritis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
General disorders
Pain
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Olygohydramnios
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Congenital, familial and genetic disorders
Congenital megaureter
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Endometritis decidual
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.38%
2/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.19%
1/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Congenital, familial and genetic disorders
Pulmonary malformation
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Reproductive system and breast disorders
Inguinal hernia
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/397 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/529 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/523 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/522 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.00%
0/507 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
0.20%
1/495 • Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER