Trial Outcomes & Findings for The Safety of Boostrix Following Routine Immunization of Pregnant Women (NCT NCT03463577)
NCT ID: NCT03463577
Last Updated: 2022-05-18
Results Overview
The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse events assessed were pre-eclampsia and eclampsia; Intra-uterine infections.
Recruitment status
COMPLETED
Target enrollment
65783 participants
Primary outcome timeframe
From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
Results posted on
2022-05-18
Participant Flow
Data was collected for both pregnant women and their infants from Kaiser Permanente Southern California (KPSC) Electronic Health Records (EHR).
The study population for the first analysis includes pregnant women who received Tdap (Boostrix) vaccine on or after the first day of the 27th week of pregnancy (Exposed cohort-on or after 1st day of 27th week of pregnancy) and their infants, as well as the matched unexposed pregnant women and their infants (Unexposed historical cohort). A second analysis was performed on pregnant women who received the Tdap vaccine before the 1st day of the 27th week of pregnancy, and their infants.
Participant milestones
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
|
Unexposed Historical Cohort Infants
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
|
Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16606
|
16606
|
65
|
16350
|
16088
|
68
|
|
Overall Study
COMPLETED
|
16366
|
16166
|
65
|
16335
|
16071
|
68
|
|
Overall Study
NOT COMPLETED
|
240
|
440
|
0
|
15
|
17
|
0
|
Reasons for withdrawal
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
|
Unexposed Historical Cohort Infants
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
|
Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
238
|
435
|
0
|
0
|
0
|
0
|
|
Overall Study
With unknown pregnancy outcome
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
Maternal death
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Neonatal death
|
0
|
0
|
0
|
15
|
17
|
0
|
Baseline Characteristics
The Safety of Boostrix Following Routine Immunization of Pregnant Women
Baseline characteristics by cohort
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16606 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16606 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy
n=65 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy
n=16350 Participants
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
|
Unexposed Historical Cohort Infants
n=16088 Participants
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
|
Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy
n=68 Participants
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
|
Total
n=65783 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
0-1 year
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16350 Participants
n=4 Participants
|
16088 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
32506 Participants
n=8 Participants
|
|
Age, Customized
13 -51 year
|
16606 Participants
n=5 Participants
|
16606 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
33277 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
16606 Participants
n=5 Participants
|
16606 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
7950 Participants
n=4 Participants
|
7725 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
48988 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8400 Participants
n=4 Participants
|
8363 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
16795 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2974 Participants
n=5 Participants
|
2974 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5962 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1274 Participants
n=5 Participants
|
1274 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2553 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9689 Participants
n=5 Participants
|
9689 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
19409 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2144 Participants
n=5 Participants
|
2144 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4298 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other-Unspecified
|
525 Participants
n=5 Participants
|
525 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16350 Participants
n=4 Participants
|
16088 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
33561 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeksPopulation: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed.
The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse events assessed were pre-eclampsia and eclampsia; Intra-uterine infections.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16606 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16606 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Person-years) of Pre-specified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort-women Groups
Pre-eclampsia and eclampsia
|
316.16 Events per 1000 persons-year
Interval 296.24 to 337.42
|
219.00 Events per 1000 persons-year
Interval 202.13 to 237.28
|
|
Incidence Rate (Per 1000 Person-years) of Pre-specified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort-women Groups
Intra-uterine infections
|
292.53 Events per 1000 persons-year
Interval 273.56 to 312.81
|
207.35 Events per 1000 persons-year
Interval 191.12 to 224.95
|
PRIMARY outcome
Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeksPopulation: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed.
Incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse event assessed was preterm delivery.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=15767 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=15551 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Prespecified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
|
64.63 Events per 1000 persons
Interval 60.9 to 68.58
|
92.28 Events per 1000 persons
Interval 87.84 to 96.94
|
PRIMARY outcome
Timeframe: From birth through 6 months of agePopulation: The analysis was performed on live singleton infants for whom the event could be assessed and who born to women from Exposed cohort women-on or after 1st day of 27th week of pregnancy group and Unexposed historical cohort women group, who met eligibility criteria.
The incidence rate (per 1000) of adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The pre-specified infant adverse event assessed was small for gestational age.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=15892 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=15626 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Pre-specified Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
|
80.42 Events per 1000 persons
Interval 76.3 to 84.76
|
75.00 Events per 1000 persons
Interval 70.98 to 79.25
|
SECONDARY outcome
Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeksPopulation: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed. Incidence rate of maternal death was not calculated for Unexposed Historical Cohort Women Group as none were reported in this group.
The incidence rate (per 1000) of other maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16606 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16606 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Poor fetal growth
|
116.00 Events per 1000 persons-year
Interval 103.99 to 129.4
|
137.63 Events per 1000 persons-year
Interval 124.29 to 152.4
|
|
Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Placental abruption
|
56.63 Events per 1000 persons-year
Interval 48.45 to 66.19
|
44.59 Events per 1000 persons-year
Interval 37.3 to 53.32
|
|
Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Preterm pre-labor rupture of membranes
|
115.53 Events per 1000 persons-year
Interval 103.52 to 128.94
|
141.52 Events per 1000 persons-year
Interval 127.95 to 156.53
|
|
Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Maternal death
|
0.43 Events per 1000 persons-year
Interval 0.11 to 1.72
|
—
|
SECONDARY outcome
Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeksPopulation: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of stillbirth/fetal death with congenital anomalies was not calculated for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups as none were reported in these groups.
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; transfusion during delivery hospitalization.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16368 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16166 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Stillbirth/fetal death
|
1.41 Events per 1000 persons
Interval 0.93 to 2.11
|
2.41 Events per 1000 persons
Interval 1.76 to 3.3
|
|
Incidence Rate (Per 1000 Persons) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Transfusion during delivery hospitalization
|
12.79 Events per 1000 persons
Interval 11.17 to 14.65
|
12.02 Events per 1000 persons
Interval 10.43 to 13.84
|
SECONDARY outcome
Timeframe: From birth through 6 months of agePopulation: The analysis was performed on live singleton infants for whom the specified event could be assessed, and who born to women from Exposed cohort women-on or after 1st day of 27th week of pregnancy group and Unexposed historical cohort women group, who met the eligibility criteria.
The incidence rate (per 1000) of other infant adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other infant adverse events assessed were neonatal death, congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16350 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16088 Participants
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Neonatal death
|
0.92 Events per 1000 persons
Interval 0.55 to 1.52
|
1.06 Events per 1000 persons
Interval 0.66 to 1.7
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of nervous system
|
2.81 Events per 1000 persons
Interval 2.11 to 3.76
|
2.36 Events per 1000 persons
Interval 1.72 to 3.25
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of eye
|
69.85 Events per 1000 persons
Interval 66.05 to 73.87
|
60.48 Events per 1000 persons
Interval 56.91 to 64.28
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of ear, face, or neck
|
16.27 Events per 1000 persons
Interval 14.43 to 18.35
|
8.14 Events per 1000 persons
Interval 6.86 to 9.66
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of cardiovascular system
|
24.40 Events per 1000 persons
Interval 22.15 to 26.89
|
21.82 Events per 1000 persons
Interval 19.67 to 24.2
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of respiratory system
|
13.76 Events per 1000 persons
Interval 12.08 to 15.68
|
10.32 Events per 1000 persons
Interval 8.86 to 12.01
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Clefts
|
1.96 Events per 1000 persons
Interval 1.38 to 2.77
|
1.49 Events per 1000 persons
Interval 1.0 to 2.23
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of upper gastrointestinal system
|
67.83 Events per 1000 persons
Interval 64.08 to 71.79
|
37.85 Events per 1000 persons
Interval 35.02 to 40.92
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of lower gastrointestinal system
|
1.35 Events per 1000 persons
Interval 0.89 to 2.04
|
2.30 Events per 1000 persons
Interval 1.67 to 3.17
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of genital organs
|
21.71 Events per 1000 persons
Interval 19.57 to 24.09
|
18.46 Events per 1000 persons
Interval 16.48 to 20.68
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of renal system
|
7.83 Events per 1000 persons
Interval 6.58 to 9.31
|
5.91 Events per 1000 persons
Interval 4.83 to 7.22
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of musculoskeletal system
|
16.27 Events per 1000 persons
Interval 14.43 to 18.35
|
10.63 Events per 1000 persons
Interval 9.15 to 12.35
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of limb
|
7.09 Events per 1000 persons
Interval 5.91 to 8.51
|
6.90 Events per 1000 persons
Interval 5.73 to 8.31
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Congenital anomalies of integument
|
58.04 Events per 1000 persons
Interval 54.57 to 61.74
|
29.65 Events per 1000 persons
Interval 27.14 to 32.39
|
|
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
Other and unspecified congenital anomalies
|
1.96 Events per 1000 persons
Interval 1.38 to 2.77
|
2.05 Events per 1000 persons
Interval 1.46 to 2.89
|
SECONDARY outcome
Timeframe: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeksPopulation: The analysis was performed on women from Exposed cohort women-before 1st day of 27th week of pregnancy group who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of placental abruption and maternal death was not calculated for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group as none were reported in this group.
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were pre-eclampsia and eclampsia; intra-uterine infections; poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=65 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Pre-eclampsia and eclampsia
|
354.50 Events per 1000 persons-year
Interval 146.26 to 755.09
|
—
|
|
Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Intra-uterine infections
|
176.42 Events per 1000 persons-year
Interval 45.85 to 525.92
|
—
|
|
Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Poor fetal growth
|
119.75 Events per 1000 persons-year
Interval 20.81 to 453.17
|
—
|
|
Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Preterm pre-labor rupture of membranes
|
117.65 Events per 1000 persons-year
Interval 20.45 to 445.22
|
—
|
SECONDARY outcome
Timeframe: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeksPopulation: The analysis was performed on women from Exposed cohort women-before 1st day of 27th week of pregnancy group who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of stillbirth/fetal death, stillbirth/fetal death with congenital anomalies, spontaneous abortion with congenital anomalies, therapeutic abortion, or therapeutic abortion with congenital anomalies was not calculated for the analyzed group as none were reported in this group.
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. The adverse events of this analysis include the adverse events presented in the above outcomes as well as spontaneous and therapeutic abortion with or without congenital anomalies in pregnant women vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; spontaneous abortion; spontaneous abortion with congenital anomalies; therapeutic abortion; therapeutic abortion with congenital anomalies; transfusion during delivery hospitalization; preterm delivery.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=65 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Spontaneous abortion
|
15.38 Events per 1000 persons
Interval 0.8 to 94.03
|
—
|
|
Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Transfusion during delivery hospitalization
|
15.63 Events per 1000 persons
Interval 0.82 to 95.41
|
—
|
|
Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
Preterm delivery
|
46.88 Events per 1000 persons
Interval 12.18 to 139.59
|
—
|
SECONDARY outcome
Timeframe: From birth through 6 months of agePopulation: The analysis was performed on infants for whom the specified event could be assessed, who were born to women from Exposed cohort women-before 1st day of 27th week of pregnancy group, and who met the eligibility criteria. Incidence rate of neonatal death; clefts; congenital anomalies of: nervous system, respiratory system; lower gastrointestinal system, limb, or other and unspecified congenital anomalies was not calculated for the analyzed group as none were reported in this group.
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The adverse events of this analysis include adverse events presented in the above outcomes, among the infants whose mothers were vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these infant adverse events was descriptive. The infant adverse events assessed were: small for gestational age; neonatal death; congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
Outcome measures
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=68 Participants
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
|---|---|---|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Small for gestational age
|
116.67 Events per 1000 persons
Interval 52.1 to 231.77
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of eye
|
88.24 Events per 1000 persons
Interval 36.38 to 188.56
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of ear, face, or neck
|
73.53 Events per 1000 persons
Interval 27.39 to 170.21
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of cardiovascular system
|
14.71 Events per 1000 persons
Interval 0.77 to 90.12
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of upper gastrointestinal system
|
14.71 Events per 1000 persons
Interval 0.77 to 90.12
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of genital organs
|
44.12 Events per 1000 persons
Interval 11.46 to 131.9
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of renal system
|
14.71 Events per 1000 persons
Interval 0.77 to 90.12
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of musculoskeletal system
|
14.71 Events per 1000 persons
Interval 0.77 to 90.12
|
—
|
|
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
Congenital anomalies of integument
|
102.94 Events per 1000 persons
Interval 45.87 to 206.51
|
—
|
Adverse Events
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
Serious events: 3733 serious events
Other events: 0 other events
Deaths: 2 deaths
Unexposed Historical Cohort Women
Serious events: 3679 serious events
Other events: 0 other events
Deaths: 0 deaths
Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy
Serious events: 5540 serious events
Other events: 0 other events
Deaths: 15 deaths
Unexposed Historical Cohort Infants
Serious events: 4211 serious events
Other events: 0 other events
Deaths: 17 deaths
Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy
n=16606 participants at risk
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Unexposed Historical Cohort Women
n=16606 participants at risk
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy
|
Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy
n=65 participants at risk
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy
|
Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy
n=16350 participants at risk
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group
|
Unexposed Historical Cohort Infants
n=16088 participants at risk
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group
|
Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy
n=68 participants at risk
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group
|
|---|---|---|---|---|---|---|
|
General disorders
Preeclampsia/eclampsia
|
5.3%
874/16606 • Number of events 874 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.5%
588/16606 • Number of events 588 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
9.2%
6/65 • Number of events 6 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Intra-uterine infections
|
4.9%
811/16606 • Number of events 811 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.4%
558/16606 • Number of events 558 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
4.6%
3/65 • Number of events 3 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Small for gestational age
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
8.0%
1278/15892 • Number of events 1278 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
7.5%
1172/15626 • Number of events 1172 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
11.7%
7/60 • Number of events 7 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Preterm delivery
|
6.5%
1019/15767 • Number of events 1019 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
9.2%
1435/15551 • Number of events 1435 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
4.7%
3/64 • Number of events 3 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Transfusion during delivery hospitalization
|
1.3%
209/16335 • Number of events 209 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.2%
193/16062 • Number of events 193 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.6%
1/64 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Poor fetal growth
|
1.9%
320/16606 • Number of events 320 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
2.2%
368/16606 • Number of events 368 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.1%
2/65 • Number of events 2 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Placental abruption
|
0.95%
157/16606 • Number of events 157 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.72%
120/16606 • Number of events 120 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/65 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Preterm pre-labor rupture of membranes
|
2.0%
318/16022 • Number of events 318 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
2.4%
378/16022 • Number of events 378 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.1%
2/65 • Number of events 2 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of nervous system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.28%
46/16350 • Number of events 46 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.24%
38/16088 • Number of events 38 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of eye
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
7.0%
1142/16350 • Number of events 1142 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
6.0%
973/16088 • Number of events 973 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
8.8%
6/68 • Number of events 6 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of ear, face or neck
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.6%
266/16350 • Number of events 266 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.81%
131/16088 • Number of events 131 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
7.4%
5/68 • Number of events 5 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of cardiovascular system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
2.4%
399/16350 • Number of events 399 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
2.2%
351/16088 • Number of events 351 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.5%
1/68 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of respiratory system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.4%
225/16350 • Number of events 225 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.0%
166/16088 • Number of events 166 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Clefts
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.20%
32/16350 • Number of events 32 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.15%
24/16088 • Number of events 24 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of upper gastrointestinal system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
6.8%
1109/16350 • Number of events 1109 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.8%
609/16088 • Number of events 609 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.5%
1/68 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of lower gastrointestinal system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.13%
22/16350 • Number of events 22 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.23%
37/16088 • Number of events 37 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of genital organs
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
2.2%
355/16350 • Number of events 355 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.8%
297/16088 • Number of events 297 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
4.4%
3/68 • Number of events 3 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of renal system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.78%
128/16350 • Number of events 128 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.59%
95/16088 • Number of events 95 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.5%
1/68 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of musculoskeletal system
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.6%
266/16350 • Number of events 266 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.1%
171/16088 • Number of events 171 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.5%
1/68 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of limb
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.71%
116/16350 • Number of events 116 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.69%
111/16088 • Number of events 111 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Congenital anomalies of integument
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
5.8%
949/16350 • Number of events 949 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
3.0%
477/16088 • Number of events 477 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
10.3%
7/68 • Number of events 7 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Other and unspecified congenital anomalies
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.20%
32/16350 • Number of events 32 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.21%
33/16088 • Number of events 33 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Spontaneous abortion
|
0.00%
0/16606 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/16606 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
1.5%
1/65 • Number of events 1 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Maternal deaths
|
0.01%
2/16606 • Number of events 2 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/16606 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/65 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Stillbirths/fetal deaths without congenital anomalies
|
0.14%
23/16368 • Number of events 23 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.24%
39/16166 • Number of events 39 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/65 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
|
General disorders
Neonatal deaths
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
—
0/0 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.09%
15/16350 • Number of events 15 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.11%
17/16088 • Number of events 17 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
0.00%
0/68 • For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.
Classification of events as SAE/other AE is unknown, all events were reported in SAE section. SAEs data was collected from different analytic populations for whom the event could be evaluated. Therefore for: Preterm delivery, Preterm pre-labor rupture of membranes, Stillbirths/fetal deaths without congenital anomalies, Transfusion during delivery hospitalization, Small for gestational age, the number of participants at risk differs from total number at risk for SAEs reported in all Arms.
|
Other adverse events
Adverse event data not reported
Additional Information
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