Trial Outcomes & Findings for Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project (NCT NCT00116272)
NCT ID: NCT00116272
Last Updated: 2023-10-06
Results Overview
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Recruitment status
COMPLETED
Target enrollment
830 participants
Primary outcome timeframe
From birth through 1 year of age
Results posted on
2023-10-06
Participant Flow
Participants were recruited concurrently from callers to Organization of Teratology Information Specialists (OTIS) centers, from health care providers and through direct to consumer marketing efforts. A third cohort of historical controls including 296 women was also included in the study but are not included in the results of this report.
The first participant was recruited in April, 2005 and recruitment continued through March 19, 2012.
Participant milestones
| Measure |
Etanercept-Exposed
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Overall Study
STARTED
|
370
|
164
|
|
Overall Study
COMPLETED
|
359
|
158
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Etanercept-Exposed
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
Baseline Characteristics
Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
Baseline characteristics by cohort
| Measure |
Etanercept-Exposed
n=370 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=164 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
Total
n=534 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 25 years
|
21 participants
n=5 Participants
|
7 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
25 - 29 years
|
81 participants
n=5 Participants
|
34 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Age, Customized
30 - 34 years
|
132 participants
n=5 Participants
|
48 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Age, Customized
> 34 years
|
136 participants
n=5 Participants
|
75 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
370 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
534 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
292 participants
n=5 Participants
|
138 participants
n=7 Participants
|
430 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
42 participants
n=5 Participants
|
13 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
18 participants
n=5 Participants
|
6 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Maternal Education
< 12 years
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Maternal Education
12 - 15 years
|
118 participants
n=5 Participants
|
42 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Maternal Education
> 15 years
|
243 participants
n=5 Participants
|
118 participants
n=7 Participants
|
361 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
1
|
134 participants
n=5 Participants
|
69 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
2
|
145 participants
n=5 Participants
|
67 participants
n=7 Participants
|
212 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
3
|
59 participants
n=5 Participants
|
19 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
4
|
23 participants
n=5 Participants
|
6 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
5
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Hollingshead Socioeconomic Category
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Pre-pregnancy Height
|
164.7 cm
STANDARD_DEVIATION 7.1 • n=5 Participants
|
166.7 cm
STANDARD_DEVIATION 7.0 • n=7 Participants
|
165.3 cm
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Pre-pregnancy Body Weight
|
70.2 kg
STANDARD_DEVIATION 18.14 • n=5 Participants
|
68.3 kg
STANDARD_DEVIATION 16.5 • n=7 Participants
|
69.6 kg
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Gravidity Category
1 pregnancy
|
135 participants
n=5 Participants
|
62 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Gravidity Category
2 -3 pregnancies
|
163 participants
n=5 Participants
|
78 participants
n=7 Participants
|
241 participants
n=5 Participants
|
|
Gravidity Category
4 -5 pregnancies
|
60 participants
n=5 Participants
|
21 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Gravidity Category
≥ 6 pregnancies
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Parity Category
0 births
|
193 participants
n=5 Participants
|
88 participants
n=7 Participants
|
281 participants
n=5 Participants
|
|
Parity Category
1 -2 births
|
153 participants
n=5 Participants
|
69 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Parity Category
3 - 4 births
|
22 participants
n=5 Participants
|
7 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Parity Category
≥ 5 births
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Previous Spontaneous Abortion
0
|
265 participants
n=5 Participants
|
117 participants
n=7 Participants
|
382 participants
n=5 Participants
|
|
Previous Spontaneous Abortion
1
|
73 participants
n=5 Participants
|
30 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Previous Spontaneous Abortion
2
|
22 participants
n=5 Participants
|
11 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Previous Spontaneous Abortion
≥ 3
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Previous Elective Terminations
0
|
314 participants
n=5 Participants
|
150 participants
n=7 Participants
|
464 participants
n=5 Participants
|
|
Previous Elective Terminations
1
|
49 participants
n=5 Participants
|
12 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Previous Elective Terminations
2
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Previous Elective Terminations
≥ 3
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous Preterm Delivery
Yes
|
37 participants
n=5 Participants
|
6 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Previous Preterm Delivery
No
|
333 participants
n=5 Participants
|
158 participants
n=7 Participants
|
491 participants
n=5 Participants
|
|
Any Previous Child with Birth Defect
Yes
|
20 participants
n=5 Participants
|
8 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Any Previous Child with Birth Defect
No
|
350 participants
n=5 Participants
|
156 participants
n=7 Participants
|
506 participants
n=5 Participants
|
|
In Vitro Fertilization (IVF) with This Pregnancy
Yes
|
27 participants
n=5 Participants
|
5 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
In Vitro Fertilization (IVF) with This Pregnancy
No
|
343 participants
n=5 Participants
|
159 participants
n=7 Participants
|
502 participants
n=5 Participants
|
|
Gestational Age at Time of Enrollment
< 13 weeks
|
196 participants
n=5 Participants
|
84 participants
n=7 Participants
|
280 participants
n=5 Participants
|
|
Gestational Age at Time of Enrollment
13 - 19.9 weeks
|
99 participants
n=5 Participants
|
58 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Gestational Age at Time of Enrollment
≥ 20 weeks
|
75 participants
n=5 Participants
|
22 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Referral Source Category
Sponsor
|
37 participants
n=5 Participants
|
1 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Referral Source Category
Health-care Professional (HCP)
|
185 participants
n=5 Participants
|
53 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Referral Source Category
Internet
|
65 participants
n=5 Participants
|
27 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Referral Source Category
Patient Support Group
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Referral Source Category
OTIS Member Service
|
29 participants
n=5 Participants
|
69 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Referral Source Category
Other
|
53 participants
n=5 Participants
|
10 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Referral Source Category
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Geographic Area of Residence
United States
|
338 participants
n=5 Participants
|
136 participants
n=7 Participants
|
474 participants
n=5 Participants
|
|
Geographic Area of Residence
Canada
|
31 participants
n=5 Participants
|
27 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Geographic Area of Residence
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Maternal Comorbidities
Thyroid Disease
|
45 participants
n=5 Participants
|
23 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Maternal Comorbidities
Asthma
|
48 participants
n=5 Participants
|
33 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Maternal Comorbidities
Other Autoimmune Disease
|
43 participants
n=5 Participants
|
17 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Maternal Comorbidities
Antidepressant Medication Use in Any Trimester
|
28 participants
n=5 Participants
|
14 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Maternal Comorbidities
Pre-gestational Hypertension
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Maternal Comorbidities
Preeclampsia
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Maternal Comorbidities
Other Psychiatric Conditions
|
64 participants
n=5 Participants
|
32 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Maternal Comorbidities
Infections
|
274 participants
n=5 Participants
|
114 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Prenatal Multivitamin or Folic Acid Supplements
Began Prior to Conception
|
217 participants
n=5 Participants
|
114 participants
n=7 Participants
|
331 participants
n=5 Participants
|
|
Prenatal Multivitamin or Folic Acid Supplements
Post-conception Only
|
148 participants
n=5 Participants
|
50 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Prenatal Multivitamin or Folic Acid Supplements
Not Taken at All
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Alcohol Use During Pregnancy
Yes
|
177 participants
n=5 Participants
|
80 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
Alcohol Use During Pregnancy
No
|
193 participants
n=5 Participants
|
84 participants
n=7 Participants
|
277 participants
n=5 Participants
|
|
Tobacco Use During Pregnancy
Yes
|
40 participants
n=5 Participants
|
17 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Tobacco Use During Pregnancy
No
|
330 participants
n=5 Participants
|
147 participants
n=7 Participants
|
477 participants
n=5 Participants
|
|
Major Known or Suspected Human Teratogens
Yes
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Major Known or Suspected Human Teratogens
No
|
356 participants
n=5 Participants
|
153 participants
n=7 Participants
|
509 participants
n=5 Participants
|
|
Intended Pregnancy
Yes
|
264 participants
n=5 Participants
|
123 participants
n=7 Participants
|
387 participants
n=5 Participants
|
|
Intended Pregnancy
No
|
106 participants
n=5 Participants
|
41 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Primary Disease (RA, JRA, PsA or AS)
Yes
|
311 participants
n=5 Participants
|
117 participants
n=7 Participants
|
428 participants
n=5 Participants
|
|
Primary Disease (RA, JRA, PsA or AS)
No
|
59 participants
n=5 Participants
|
47 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Duration of Disease
|
9.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Prednisone and/or Systemic Oral Corticosteroid
Yes
|
163 participants
n=5 Participants
|
65 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Prednisone and/or Systemic Oral Corticosteroid
No
|
207 participants
n=5 Participants
|
99 participants
n=7 Participants
|
306 participants
n=5 Participants
|
|
Disease Severity Score - RA
|
0.5 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
0.5 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Disease Severity Score - PsO
|
2.0 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Exposed to Etanercept
First Trimester
|
344 participants
n=5 Participants
|
0 participants
n=7 Participants
|
344 participants
n=5 Participants
|
|
Exposed to Etanercept
Last Menstrual Period to Date of Conception
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Exposed to Etanercept
2nd and/or 3rd Trimester Only
|
13 participants
n=5 Participants
|
0 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Exposed to Etanercept
Started Prior to DOC, End Date Unavailable
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From birth through 1 year of agePopulation: Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Outcome measures
| Measure |
Etanercept-Exposed
n=319 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=144 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
|
9.4 percentage of participants
|
3.5 percentage of participants
|
PRIMARY outcome
Timeframe: From birth through 1 year of agePopulation: Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort.
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Outcome measures
| Measure |
Etanercept-Exposed
n=335 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=158 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Major Birth Defects in All Pregnancies
|
9.9 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: From birth through 1 year of agePopulation: Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Outcome measures
| Measure |
Etanercept-Exposed
n=257 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=111 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Any 3 or More Minor Birth Defects
|
25.7 percentage of infants
|
22.5 percentage of infants
|
SECONDARY outcome
Timeframe: From birth through 1 year of agePopulation: Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.
Outcome measures
| Measure |
Etanercept-Exposed
n=262 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=113 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects
|
2.3 percentage of infants
|
0.0 percentage of infants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).
Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.
Outcome measures
| Measure |
Etanercept-Exposed
n=288 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=137 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Pregnancies Ending in Spontaneous Abortion
|
14.7 percentage of pregnancies
Interval 7.4 to 28.3
|
28.8 percentage of pregnancies
Interval 16.0 to 48.5
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births.
A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks' gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.
Outcome measures
| Measure |
Etanercept-Exposed
n=324 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=142 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Participants With Pre-term Delivery
|
13.9 percentage of participants
Interval 10.5 to 18.2
|
10.0 percentage of participants
Interval 6.1 to 16.3
|
SECONDARY outcome
Timeframe: At birthPopulation: Live births in women enrolled and exposed to etanercept prior to 37 weeks' gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births.
Outcome measures
| Measure |
Etanercept-Exposed
n=324 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=142 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Gestational Age at Delivery (GAD) of Live Births
|
38.6 weeks
Standard Deviation 2.2
|
38.8 weeks
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: At birthPopulation: Live birth full-term infants, excluding multiple births, where data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=282 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=128 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Birth Weight Among Full Term Infants
|
3399.1 g
Standard Deviation 434.9
|
3380.2 g
Standard Deviation 447.0
|
SECONDARY outcome
Timeframe: At birthPopulation: Live birth full-term infants, excluding multiple births, where data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=277 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=127 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Birth Length Among Full Term Infants
|
50.8 cm
Standard Deviation 2.6
|
50.7 cm
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: At birthPopulation: Live birth full-term infants, excluding multiple births, where data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=253 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=116 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Birth Head Circumference Among Full Term Infants
|
34.4 cm
Standard Deviation 1.6
|
34.5 cm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At birthPopulation: Live-born infants, excluding multiple births, where data were available.
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Outcome measures
| Measure |
Etanercept-Exposed
n=324 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=141 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Small for Gestational Age Birth Weight
|
6.8 percentage of infants
|
10.6 percentage of infants
|
SECONDARY outcome
Timeframe: At birthPopulation: Live-born infants, excluding multiple births, where data were available.
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Outcome measures
| Measure |
Etanercept-Exposed
n=317 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=139 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Small for Gestational Age Birth Length
|
4.7 percentage of infants
|
6.5 percentage of infants
|
SECONDARY outcome
Timeframe: At birthPopulation: Live-born infants, excluding multiple births, where data were available.
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Outcome measures
| Measure |
Etanercept-Exposed
n=287 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=125 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Small for Gestational Age Birth Head Circumference
|
17.1 percentage of infants
|
14.4 percentage of infants
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where 1-year data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=248 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=108 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Postnatal Weight Percentile at One Year
|
45.1 percentile
Standard Deviation 30.1
|
44.1 percentile
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where 1-year data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=251 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=110 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Postnatal Length Percentile at One Year
|
60.1 percentile
Standard Deviation 29.7
|
62.3 percentile
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where 1-year data were available
Outcome measures
| Measure |
Etanercept-Exposed
n=243 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=108 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Postnatal Head Circumference Percentile at One Year
|
63.9 percentile
Standard Deviation 28.3
|
63.8 percentile
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where data were available.
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Outcome measures
| Measure |
Etanercept-Exposed
n=248 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=108 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants at One Year of Age With Small for Gestational Age Weight
|
14.5 percentage of infants
|
13.9 percentage of infants
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where data were available.
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Outcome measures
| Measure |
Etanercept-Exposed
n=251 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=110 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants at One Year of Age With Small for Gestational Age Length
|
7.2 percentage of infants
|
5.5 percentage of infants
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, excluding multiple births, where data were available.
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Outcome measures
| Measure |
Etanercept-Exposed
n=243 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=108 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference
|
4.1 percentage of infants
|
4.6 percentage of infants
|
SECONDARY outcome
Timeframe: From birth to 1 yearPopulation: Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).
Outcome measures
| Measure |
Etanercept-Exposed
n=342 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=144 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year
|
5.3 Percentage of infants
|
4.2 Percentage of infants
|
SECONDARY outcome
Timeframe: From birth to 1 yearPopulation: Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).
Outcome measures
| Measure |
Etanercept-Exposed
n=342 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=144 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age
|
0 Percentage of infants
|
0 Percentage of infants
|
SECONDARY outcome
Timeframe: 1 year after birthPopulation: Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.
The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: "Yes," "Sometimes," "Not Yet," with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported.
Outcome measures
| Measure |
Etanercept-Exposed
n=287 Participants
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Diseased Controls
n=117 Participants
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
|---|---|---|
|
Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)
|
28.2 Percentage of infants
|
27.4 Percentage of infants
|
Adverse Events
Mothers Diseased Control
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Mothers Etanercept Exposed
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Infants Diseased Control
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Infants Etanercept Exposed
Serious events: 59 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mothers Diseased Control
n=164 participants at risk
Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
Mothers Etanercept Exposed
n=370 participants at risk
Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
Infants Diseased Control
n=146 participants at risk
Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
|
Infants Etanercept Exposed
n=352 participants at risk
Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia neonatal
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Cardiac disorders
Atrial hypertrophy
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
2.6%
9/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital aortic valve incompetence
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital cardiovascular anomaly
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital cystic lung
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital eye disorder
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital gastric anomaly
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Congenital mitral valve incompetence
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Double ureter
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Epispadias
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Haemangioma congenital
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Heart block congenital
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Kidney duplex
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Limb reduction defect
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Microcephaly
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.85%
3/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Micropenis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Noonan syndrome
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Pulmonary artery stenosis congenital
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Pulmonary valve stenosis congenital
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
1.1%
4/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Transposition of the great vessels
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Trisomy 13
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
1.4%
2/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Turner's syndrome
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.85%
3/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.61%
1/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.54%
2/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
General disorders
Death
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
General disorders
Developmental delay
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
General disorders
Pyrexia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Abscess
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.61%
1/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.54%
2/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Group B streptococcus neonatal sepsis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Influenza
|
0.61%
1/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Meningitis neonatal
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.54%
2/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
2.0%
7/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Pyelonephritis
|
0.61%
1/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.85%
3/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
1.7%
6/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Uterine infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
7.9%
13/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
4.6%
17/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.85%
3/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Renal and urinary disorders
Reflux nephropathy
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Reproductive system and breast disorders
Shortened cervix
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.27%
1/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Immature respiratory system
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.57%
2/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery stenosis
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.68%
1/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Surgical and medical procedures
Abortion induced
|
0.61%
1/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.81%
3/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
|
Surgical and medical procedures
Transplant
|
0.00%
0/164 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/370 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.00%
0/146 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
0.28%
1/352 • Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER