Trial Outcomes & Findings for Randomized Trial of Maternal Progesterone Therapy (NCT NCT02133573)
NCT ID: NCT02133573
Last Updated: 2023-08-09
Results Overview
The composite motor score is normed and has a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
When baby is 18 months of age
Results posted on
2023-08-09
Participant Flow
Participants were recruited from the Cardiac Center at Children's Hospital of Philadelphia (CHOP) between July 2014 and February 2020.102 maternal subjects and their fetuses (dyads) were enrolled. On February 26, 2020 it was the unanimous opinion of the Data Safety Monitoring Board (DSMB) that enrollment in the trial should be stopped for futility.
Participant milestones
| Measure |
Progesterone
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
Dyads Allocated to Intervention
|
52
|
49
|
|
Overall Study
Number of Toddlers That Returned for 18 Month Follow Up Visit
|
45
|
43
|
|
Overall Study
Number of Toddlers With Analyzed Primary Endpoint
|
43
|
42
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Progesterone
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
|---|---|---|
|
Overall Study
Withdrawal by Maternal Subjects
|
2
|
1
|
|
Overall Study
Child Deaths
|
3
|
5
|
|
Overall Study
Child Declined Follow Ups
|
2
|
1
|
|
Overall Study
Child missing primary endpoint score due to child's inability to test
|
2
|
1
|
Baseline Characteristics
Randomized Trial of Maternal Progesterone Therapy
Baseline characteristics by cohort
| Measure |
Progesterone
n=52 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=50 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 weeks
STANDARD_DEVIATION 0.606 • n=99 Participants
|
27.7 weeks
STANDARD_DEVIATION 0.597 • n=107 Participants
|
27.8 weeks
STANDARD_DEVIATION 0.599 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Marital Status
Single
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Marital Status
Married
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Mom Works Outside Home
Yes
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Mom Works Outside Home
No
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Income
Less than 25,000
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Income
25,000-50,000
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Income
51,000-75,000
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Income
76,000-100,000
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Income
Greater than 100,000
|
19 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Income
Don't know
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Income
Prefer not to answer
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
Missing
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Maternal Education
Partial high school
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Maternal Education
Graduated high school (12th grade)
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Maternal Education
Partial college or trade school
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Maternal Education
College graduate
|
17 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Maternal Education
Post graduate degree
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Fetal Cardiac Diagnosis
Hypoplastic Left Heart Syndrome (HLHS)
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Fetal Cardiac Diagnosis
Transposition of the Great Arteries (TGA)
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Fetal Cardiac Diagnosis
OTHER
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Child Genetic Classification
Normal
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Child Genetic Classification
Suspect
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Child Genetic Classification
Abnormal
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Child Genetic Classification
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child Genetic Classification
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Child 22q11.2 Deletion
Yes
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Child 22q11.2 Deletion
No
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Child 22q11.2 Deletion
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child 22q11.2 Deletion
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Child Apolipoprotein E (APOE) Haplotype
E2
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Child Apolipoprotein E (APOE) Haplotype
E2/E4
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child Apolipoprotein E (APOE) Haplotype
E3
|
26 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Child Apolipoprotein E (APOE) Haplotype
E4
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Child Apolipoprotein E (APOE) Haplotype
Missing
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Paternal Race
American Indian/Alaskan Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Paternal Race
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Paternal Race
Black/African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Paternal Race
White
|
38 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Paternal Race
Not known
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Paternal Race
Choose not to answer
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Paternal Race
Missing
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Paternal Race
Multiple
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Paternal Hispanic Ethnicity
Yes
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Paternal Hispanic Ethnicity
No
|
47 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Paternal Hispanic Ethnicity
Choose not to answer
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Paternal Hispanic Ethnicity
Missing
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Dad Employed
Yes
|
50 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Dad Employed
No
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Dad Employed
Missing
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Paternal Education
Graduated high school (12th grade)
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Paternal Education
Partial college or trade school
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Paternal Education
College graduate
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Paternal Education
Post graduate degree
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Paternal Education
Refused to answer
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Paternal Education
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Child Race
American Indian/Alaskan Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Child Race
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child Race
Black/African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Child Race
White
|
34 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Child Race
Choose not to answer
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child Race
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Child Race
Multiple
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Child Hispanic Ethnicity
Yes
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Child Hispanic Ethnicity
No
|
47 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Child Hispanic Ethnicity
Choose not to answer
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Child Hispanic Ethnicity
Missing
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Child Gender
Male
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Child Gender
Female
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Child Gender
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: When baby is 18 months of agePopulation: Per protocol population, all children who completed the 18 month follow up visit.
The composite motor score is normed and has a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Outcome measures
| Measure |
Progesterone
n=45 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=43 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Overall
n=88 Participants
Treatment 1 and Treatment 2 Combined
|
|---|---|---|---|
|
Motor Scale of the Bayley Scales of Infant and Toddler Development-III
|
90.0 score on a scale
Standard Deviation 11.5
|
87.5 score on a scale
Standard Deviation 12.7
|
88.7 score on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: When baby is 18 months of agePopulation: Per protocol population, all children who completed the 18 month follow up visit.
The composite cognitive and language scores are normed and have a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Outcome measures
| Measure |
Progesterone
n=45 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=43 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Overall
n=88 Participants
Treatment 1 and Treatment 2 Combined
|
|---|---|---|---|
|
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III
Bayley Cognitive Score (Composite)
|
92.4 score on a scale
Standard Deviation 12.2
|
91.2 score on a scale
Standard Deviation 11.4
|
91.8 score on a scale
Standard Deviation 11.8
|
|
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III
Bayley Language Score (Composite)
|
86.1 score on a scale
Standard Deviation 15.1
|
84.5 score on a scale
Standard Deviation 18.9
|
85.3 score on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: fTMS score change from 24-28 weeks gestational age to 34-36 weeks gestational agePopulation: Number of participants who completed both fetal MRIs and had reliable TMS scores.
Total maturation scale (TMS) is an observational rating scale to assess the appropriateness of the gross brain appearance on MRI. The TMS scale has been used to demonstrate the negative effect of heart anatomy on post-natal, pre-surgical brain MRIs in infants with congenital heart. Similarly, a fetal TMS scale (fTMS) was developed to define the progress of brain development in-utero. Here we use the fTMS to define developmental/maturational changes occurring during gestation. The fTMS was graded on an ordinal scale, minimum = 4, maximum = 17 where a lower number indicates a less mature fetal brain and a higher number indicates a more mature fetal brain on MRI.
Outcome measures
| Measure |
Progesterone
n=31 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=29 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Overall
Treatment 1 and Treatment 2 Combined
|
|---|---|---|---|
|
Fetal Brain Growth and Maturation by MRI
|
8.84 score on a scale
Standard Deviation 1.19
|
8.35 score on a scale
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Change from 24-28 weeks gestational age to 34-36 weeks gestational agePopulation: Number of participants who completed both fetal MRIs and had reliable myelination scores.
Myelination is part of the fetal TMS rating system and is scored as follows. 1. \- If there is myelin in the brainstem, cerebellar peduncle and inferior tectum only 2. \- If there is myelin in the ventrolateral thalamus as well as in #1 3. \- If there is myelin present in the posterior limb of the internal capsule as well as in #2
Outcome measures
| Measure |
Progesterone
n=32 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=29 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Overall
Treatment 1 and Treatment 2 Combined
|
|---|---|---|---|
|
Myelination During Fetal Brain Development by MRI
|
0.72 score on a scale
Standard Deviation 0.5
|
0.69 score on a scale
Standard Deviation 0.4
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—
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SECONDARY outcome
Timeframe: Preoperative on day of surgeryPopulation: The number of participants who completed a pre operative MRI.
Periventricular leukomalacia (PVL), also known in the literature as white matter injury (WMI), is an acquired brain injury to the white matter of the brain seen in 20% of infants with congenital heart and up to 80% post-operatively. PVL/WMI is seen on T1 MPR sequences as abnormal hyperintensities in the white matter which are quantified by manual segmentation to achieve total volumes and regional volumes of the injury. Yes indicates the presence of PVL and no indicates the absence of PVL on the pre operative MRI.
Outcome measures
| Measure |
Progesterone
n=35 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=34 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
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Overall
n=69 Participants
Treatment 1 and Treatment 2 Combined
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|---|---|---|---|
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Prevalence of PVL/WMI in the Pre Operative Study Participants
Yes
|
8 Participants
|
9 Participants
|
17 Participants
|
|
Prevalence of PVL/WMI in the Pre Operative Study Participants
No
|
27 Participants
|
25 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Postoperative within 10 days of surgeryPopulation: The number of participants who completed a post operative MRI.
PVL/WMI will be measured on the post operative brain MRI with manual segmentations from the T1MPR sequence. Yes indicates the presence of new or worse PVL and no indicates the absence of new or worse PVL on the post operative MRI.
Outcome measures
| Measure |
Progesterone
n=37 Participants
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant
n=36 Participants
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Overall
n=73 Participants
Treatment 1 and Treatment 2 Combined
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|---|---|---|---|
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Prevalence of PVL/WMI in the Post Operative Study Participants
Yes
|
18 Participants
|
15 Participants
|
33 Participants
|
|
Prevalence of PVL/WMI in the Post Operative Study Participants
No
|
19 Participants
|
21 Participants
|
40 Participants
|
Adverse Events
Progesterone (Maternal Adverse Events)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Vaginal Lubricant (Maternal Adverse Events)
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Progesterone (Child Adverse Events)
Serious events: 46 serious events
Other events: 48 other events
Deaths: 3 deaths
Vaginal Lubricant (Child Adverse Events)
Serious events: 43 serious events
Other events: 48 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Progesterone (Maternal Adverse Events)
n=52 participants at risk
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant (Maternal Adverse Events)
n=50 participants at risk
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Progesterone (Child Adverse Events)
n=50 participants at risk
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant (Child Adverse Events)
n=49 participants at risk
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
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|---|---|---|---|---|
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Surgical and medical procedures
Hysterectomy
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Uterine Hemorrhage
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine Atony
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
Listing for Cardiac Transplant
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Thromboelic Event
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
Heart Block
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
Hemolysis
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Surgical and medical procedures
Need for Surgical or Catheter-Based Intervention
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
92.0%
46/50 • Number of events 131 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
83.7%
41/49 • Number of events 115 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
Other adverse events
| Measure |
Progesterone (Maternal Adverse Events)
n=52 participants at risk
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant (Maternal Adverse Events)
n=50 participants at risk
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
Progesterone (Child Adverse Events)
n=50 participants at risk
Vaginal gel, 90mg twice a day (BID)
Progesterone: Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
|
Vaginal Lubricant (Child Adverse Events)
n=49 participants at risk
Vaginal twice a day (BID)
Vaginal lubricant: Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal Discharge
|
63.5%
33/52 • Number of events 43 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
64.0%
32/50 • Number of events 38 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Uterine Pain
|
21.2%
11/52 • Number of events 14 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
24.0%
12/50 • Number of events 13 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
23.1%
12/52 • Number of events 12 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
28.0%
14/50 • Number of events 15 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Nausea
|
17.3%
9/52 • Number of events 10 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
18.0%
9/50 • Number of events 9 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Headache
|
19.2%
10/52 • Number of events 12 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Vaginal Infection
|
17.3%
9/52 • Number of events 11 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
12.0%
6/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Hypertension
|
19.2%
10/52 • Number of events 10 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
15.4%
8/52 • Number of events 8 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
Edema Limbs
|
9.6%
5/52 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
12.0%
6/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
Fatigue
|
15.4%
8/52 • Number of events 8 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 8 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Delivery
|
7.7%
4/52 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
12.0%
6/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Insomnia
|
11.5%
6/52 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
9.6%
5/52 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
10.0%
5/50 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
Anemia
|
9.6%
5/52 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
6/52 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
4/52 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
4/52 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Uterine Hemorrhage
|
7.7%
4/52 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
11.5%
6/52 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
4/52 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Urinary Tract Infection
|
5.8%
3/52 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Urinary Frequency
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
10.0%
5/50 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Anxiety
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Eye disorders
Blurred Vision
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Growth Retardation
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Depression
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Libido Increased
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Breast Pain
|
3.8%
2/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.8%
3/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.8%
2/52 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
Palpitations
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Breast Infection
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Presyncope
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/52 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Eye disorders
Flashing Lights
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Eye disorders
Floaters
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
Pain
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Skin Infection
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
Infections and Infestations - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Injury, poisoning and procedural complications
Intraoperative Reproductive Tract Injury
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
Nervous System Disorders - Other
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Psychiatric disorders
Restlessness
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Bladder Spasm
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Hematuria
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Renal Calculi
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Urinary Urgency
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Reproductive system and breast disorders
Lactation Disorder
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Surgical and medical procedures
Surgical and Medical Procedures - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Hematoma
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Hot Flashes
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
1.9%
1/52 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Vascular disorders
Vascular Disorders - Other
|
0.00%
0/52 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0001 Atrial fibrillation
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0002 Atrial Flutter
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0003 Supraventricular Tachycardia
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
26.0%
13/50 • Number of events 16 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
16.3%
8/49 • Number of events 8 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0004 Junctional Ectopic Tachycardia
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0005 Sinus node dysfunction (requiring pacing)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0006 Atrioventricular block (second or third, not first)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/49 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0007 Ventricular tachycardia
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0008 Ventricular fibrillation
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0020 Hemopericardium (requiring intervention)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0021 Pericardial effusion (requiring drainage)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0030 Hypotension (<40mmHg for neonates; <50 mmHg after Stage II)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
18.0%
9/50 • Number of events 12 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.4%
11/49 • Number of events 14 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Cardiac disorders
M-0099 Other Cardiac
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
10.2%
5/49 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0101 Chronic respiratory failure (intubated for >2 weeks after surgery)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
12.0%
6/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.2%
4/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0102 Chylothorax
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 10 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.2%
4/49 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0103 Diaphragm paralysis (fluoro or ultrasound)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0104 Hemothorax
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0105 Phrenic nerve injury
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0106 Pleural effusion requiring drainage
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.0%
11/50 • Number of events 16 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
10.2%
5/49 • Number of events 5 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0107 Pneumothorax requiring tube insertion
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0109 Vocal cord injury (direct visualization)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Respiratory, thoracic and mediastinal disorders
M-0199 Other Respiratory
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0201 Abnormal head CT scan
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 11 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0202 Abnormal head MRI scan
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
70.0%
35/50 • Number of events 49 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
71.4%
35/49 • Number of events 53 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0205 Intracranial bleeding (confirmed by imaging)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
64.0%
32/50 • Number of events 41 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
67.3%
33/49 • Number of events 36 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0206 Seizure(s) - definite (EEG or obvious motor)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
18.0%
9/50 • Number of events 12 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.3%
7/49 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0207 Stroke (confirmed by imaging study)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.0%
11/50 • Number of events 11 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Nervous system disorders
M-0299 Other, Neurological
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0301 Cholestasis (Direct bilirubin >4)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0302 Hyperbilirubinemia (requiring phototherapy or direct bilirubin >5)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.2%
4/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0303 Liver failure (AST, ALT or GGT >500)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.0%
4/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0304 NEC, confirmed (pneumatosis or free air)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0305 NEC, suspected (NPO, antibiotics started)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Gastrointestinal disorders
M-0399 Other, Gastrointestinal
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
40.0%
20/50 • Number of events 22 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
32.7%
16/49 • Number of events 17 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0403 Line Infection
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0404 Mediastinitis
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0405 Sepsis, confirmed (positive blood culture, not line infection)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.0%
3/50 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
6.1%
3/49 • Number of events 3 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0406 Sepsis, suspected (antibiotics started)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
50.0%
25/50 • Number of events 47 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
49.0%
24/49 • Number of events 43 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0407 Wound infection, superficial
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
20.0%
10/50 • Number of events 10 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
20.4%
10/49 • Number of events 10 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Infections and infestations
M-0499 Other infection
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.0%
7/50 • Number of events 7 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
14.3%
7/49 • Number of events 9 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
M-0501 Acute renal failure (creatinine >1.5 or tripling of baseline value for <7 days)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
8.2%
4/49 • Number of events 4 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
M-0502 Chronic renal failure (creatinine >1.5 or tripling of baseline value for >7 days)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
M-0503 Hemodialysis
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.0%
2/50 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
4.1%
2/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Renal and urinary disorders
M-0504 Peritoneal dialysis
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
0.00%
0/50 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
M-0601 Anemia (Hemoglobin <10 gm/dl)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
38.0%
19/50 • Number of events 33 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
34.7%
17/49 • Number of events 25 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
M-0602 Thrombocytopenia (plts <50,000)
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.0%
11/50 • Number of events 16 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
18.4%
9/49 • Number of events 16 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
M-0603 Thrombus/thromboembolism
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.0%
11/50 • Number of events 14 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
22.4%
11/49 • Number of events 20 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
Blood and lymphatic system disorders
M-0699 Other, Hematologic
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/50 • Number of events 1 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
2.0%
1/49 • Number of events 2 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
|
General disorders
M-9999 Other, Misc
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
—
0/0 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
12.0%
6/50 • Number of events 6 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
18.4%
9/49 • Number of events 12 • Maternal adverse event data was collected from randomization through delivery, an average of 12 weeks. Child adverse event data was collected from birth through their follow up visit, an average of 18 months.
Maternal adverse events were collected using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v.4.0) Child adverse events were collected using Pediatric Heart Network: Single Ventricle Reconstruction Trial Code List M: Complications and Sentinel Serious Events Version A (PHN Code List M) All adverse event terms corresponding to the mothers and the children are reported separately, even if they repeat, as indicated by the associated source vocabulary name for each term.
|
Additional Information
Dr. J. William Gaynor
Children's Hospital of Philadelphia
Phone: 215-590-5806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place