Trial Outcomes & Findings for A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia (NCT NCT00850993)
NCT ID: NCT00850993
Last Updated: 2019-10-30
Results Overview
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time \[(TSB - PT threshold/PT threshold) x 100%).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline, 48 hours
Results posted on
2019-10-30
Participant Flow
Fifty-eight (58) babies were enrolled before the trial was prematurely terminated due to cancellation.
Because the cohorts were run sequentially, and the trial was cancelled before they were all enrolled, Cohort 3 enrolled only 8 compared to 15 in Cohort 4.
Participant milestones
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 4: Placebo Control
Placebo control was sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
8
|
15
|
|
Overall Study
Safety
|
17
|
18
|
8
|
15
|
|
Overall Study
Intent-to-treat
|
17
|
18
|
8
|
15
|
|
Overall Study
Received Phototherapy
|
3
|
6
|
2
|
8
|
|
Overall Study
Per Protocol
|
10
|
13
|
5
|
13
|
|
Overall Study
COMPLETED
|
16
|
18
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 4: Placebo Control
Placebo control was sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Overall Study
Parent/Guardian Voluntarily Withdrew
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Baseline characteristics by cohort
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
n=17 Participants
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
n=18 Participants
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
n=8 Participants
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 4: Placebo Control
n=15 Participants
Placebo control was sterile saline solution (with phototherapy as needed)
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
35 through 37 Weeks
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Customized
38 Weeks and Above
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 hoursPopulation: Intent-to-treat population (ITT)
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time \[(TSB - PT threshold/PT threshold) x 100%).
Outcome measures
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
n=17 Participants
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
n=18 Participants
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
n=8 Participants
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Placebo Control
n=15 Participants
Sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
|
-12.30 percentage difference from PT threshold
Interval -55.7 to 0.3
|
-9.05 percentage difference from PT threshold
Interval -54.8 to 12.0
|
-19.95 percentage difference from PT threshold
Interval -59.0 to -5.0
|
-5.7 percentage difference from PT threshold
Interval -42.1 to 22.2
|
PRIMARY outcome
Timeframe: Baseline, 48 hrsPopulation: Intention-to-treat
Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
Outcome measures
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
n=17 Participants
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
n=18 Participants
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
n=8 Participants
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Placebo Control
n=15 Participants
Sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
at Baseline
|
7.80 mg/dL
Interval 4.3 to 12.0
|
8.45 mg/dL
Interval 5.5 to 10.4
|
9.35 mg/dL
Interval 6.4 to 12.8
|
8.00 mg/dL
Interval 4.6 to 11.9
|
|
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
at 48 hours
|
10.90 mg/dL
Interval 3.3 to 13.5
|
11.65 mg/dL
Interval 4.2 to 14.1
|
10.35 mg/dL
Interval 5.6 to 13.4
|
11.90 mg/dL
Interval 8.1 to 15.8
|
|
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Change from Baseline at 48 hours
|
2.70 mg/dL
Interval -4.5 to 5.2
|
2.94 mg/dL
Interval -3.4 to 6.2
|
1.45 mg/dL
Interval -3.4 to 3.6
|
3.70 mg/dL
Interval -0.2 to 8.7
|
Adverse Events
Cohort 1: Stannsoporfin 1.5 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: Stannsoporfin 3.0 mg/kg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 3: Stannsoporfin 4.5 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Control
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
n=17 participants at risk
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
n=18 participants at risk
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
n=8 participants at risk
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Placebo Control
n=15 participants at risk
Sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
13.3%
2/15 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Infections and infestations
meningitis
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
Other adverse events
| Measure |
Cohort 1: Stannsoporfin 1.5 mg/kg
n=17 participants at risk
1.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 2: Stannsoporfin 3.0 mg/kg
n=18 participants at risk
3.0 mg/kg stannsoporfin (with phototherapy as needed)
|
Cohort 3: Stannsoporfin 4.5 mg/kg
n=8 participants at risk
4.5 mg/kg stannsoporfin (with phototherapy as needed)
|
Placebo Control
n=15 participants at risk
Sterile saline solution (with phototherapy as needed)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
25.0%
2/8 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
11.1%
2/18 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
6.7%
1/15 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Gastrointestinal disorders
Hyperbilirubinaemia
|
11.8%
2/17 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
13.3%
2/15 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Gastrointestinal disorders
Jaundice
|
29.4%
5/17 • Number of events 5 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
6.7%
1/15 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Infections and infestations
Meningitis
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
13.3%
2/15 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Investigations
Blood sodium increased
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Investigations
C-reactive protein increased
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
11.8%
2/17 • Number of events 2 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
6.7%
1/15 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
12.5%
1/8 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Erythema toxicum neonatorum
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
16.7%
3/18 • Number of events 3 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Rash neonatal
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
6.7%
1/15 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.9%
1/17 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/18 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
5.6%
1/18 • Number of events 1 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/8 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
0.00%
0/15 • 30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
|
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Phone: 1-800-844-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60