Trial Outcomes & Findings for Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age (NCT NCT05856227)
NCT ID: NCT05856227
Last Updated: 2025-07-28
Results Overview
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Up to 5-7 weeks
Results posted on
2025-07-28
Participant Flow
Treatment was administered in hospital setting
A total of 11 patients were screened for enrollment in this study, two of whom failed the screening process. Nine patients (six pre-term neonates and three term neonates) were enrolled and assigned to the study treatment
Participant milestones
| Measure |
Pre-term Neonates
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
|
Term Neonates
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Pre-term Neonates
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
|
Term Neonates
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Due to Investigator absence
|
1
|
0
|
|
Overall Study
Cerebrospinal fluid test positive for S. aureus
|
1
|
0
|
Baseline Characteristics
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Baseline characteristics by cohort
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours.
Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg/kg (bodyweight ≥ 4 kg) infused over 2 hours and administered every 12 hours.
Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.2 Days
STANDARD_DEVIATION 11.05 • n=99 Participants
|
26.7 Days
STANDARD_DEVIATION 4.51 • n=107 Participants
|
21.7 Days
STANDARD_DEVIATION 9.77 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Lithuania
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Estonia
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Gestational age
|
28.5 Weeks
STANDARD_DEVIATION 4.68 • n=99 Participants
|
39.0 Weeks
STANDARD_DEVIATION 1.73 • n=107 Participants
|
32.0 Weeks
STANDARD_DEVIATION 6.48 • n=206 Participants
|
|
Baseline weight
|
1429.2 gram
STANDARD_DEVIATION 777.49 • n=99 Participants
|
3156.7 gram
STANDARD_DEVIATION 1094.36 • n=107 Participants
|
2005.0 gram
STANDARD_DEVIATION 1193.01 • n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 5-7 weeksPopulation: The safety population consists of all enrolled patients who received at least one dose of ceftobiprole
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
Outcome measures
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs)
Any AE
|
3 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events (AEs)
Study-drug-related AE
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
SAE
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
Study-drug-related SAE
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events (AEs)
AE leading to treatment discontinuation
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
AE of special interest
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the dayPopulation: Pharmacokinetics (PK) population All patients who received at least one dose of ceftobiprole and had at least one sample of plasma concentration measurement obtained by the appropriate methodology.
Observed pharmacokinetic parameter Cmax of ceftobiprole (the active moiety), its pro-drug ceftobiprole medocaril and the open-ring metabolite in term and pre-term neonates with post-natal age up to 3 months
Outcome measures
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite
Ceftobiprole
|
17.2 μg/mL
Interval 11.0 to 22.6
|
28.4 μg/mL
Interval 19.1 to 33.8
|
|
Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite
Ceftobiprole medocaril
|
0.585 μg/mL
Interval 0.276 to 5.7
|
0.552 μg/mL
Interval 0.376 to 2.59
|
|
Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite
Open-ring metabolite
|
1.18 μg/mL
Interval 0.624 to 1.69
|
1.68 μg/mL
Interval 0.998 to 2.06
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The ITT population consists of all enrolled patients who received at least one dose of ceftobiprole.
Clinical cure rate at the end of treatment (EOT) at day 3-14 and test of cure (TOC) at 7-14 days after last ceftobiprole dose visits in the Intent-to-Treat (ITT) population
Outcome measures
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Number of Patients With a Clinical Response
TOC · Unevaluable
|
2 Participants
|
0 Participants
|
|
Number of Patients With a Clinical Response
EoT · Cure
|
4 Participants
|
2 Participants
|
|
Number of Patients With a Clinical Response
EoT · Failure
|
0 Participants
|
1 Participants
|
|
Number of Patients With a Clinical Response
EoT · Unevaluable
|
2 Participants
|
0 Participants
|
|
Number of Patients With a Clinical Response
TOC · Cure
|
4 Participants
|
2 Participants
|
|
Number of Patients With a Clinical Response
TOC · Failure
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The ITT population consists of all enrolled patients who received at least one dose of ceftobiprole.
Improved signs and symptoms of LOS (including fever, hypothermia, abnormal heart rate, signs of impaired circulation, petechial rash or sclerema neonatorum, respiratory distress, gastrointestinal distress, irritability, lethargy and/or muscular or arterial hypotonia) assessed at Day 3, EOT, and TOC visits (ITT) populations.
Outcome measures
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Day 3 · Resolved
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Day 3 · Improved
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Day 3 · Unchanged
|
3 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Day 3 · Worsened
|
0 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
Day 3 · Not done
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
EOT · Resolved
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
EOT · Improved
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
EOT · Unchanged
|
2 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
EOT · Worsened
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
EOT · Not done
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
TOC · Resolved
|
2 Participants
|
2 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
TOC · Improved
|
2 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
TOC · Unchanged
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
TOC · Worsened
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)
TOC · Not done
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The microbiological Intent-to-treat (mITT) population consists of all patients in the ITT population with a causative pathogen identified at baseline.
Microbiological eradication or presumed eradication rate at the EOT and TOC visits.
Outcome measures
| Measure |
Pre-term Neonates
n=6 Participants
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 Participants
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Number of Patients With a Microbiological Response
EOT · Eradication
|
4 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
EOT · Presumed eradication
|
0 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
EOT · Persistence
|
0 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
EOT · Unevaluable
|
2 Participants
|
0 Participants
|
|
Number of Patients With a Microbiological Response
TOC · Eradication
|
4 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
TOC · Presumed eradication
|
0 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
TOC · Persistence
|
0 Participants
|
1 Participants
|
|
Number of Patients With a Microbiological Response
TOC · Unevaluable
|
2 Participants
|
0 Participants
|
Adverse Events
Pre-term Neonates
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Term Neonates
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-term Neonates
n=6 participants at risk
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 participants at risk
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Gastrointestinal disorders
Intestinal obstruction
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
Other adverse events
| Measure |
Pre-term Neonates
n=6 participants at risk
Pediatric patients (gestational age ≥ 24 to 36 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 7.5 mg/kg or 10 mg/kg (bodyweight \< 4 kg) infused over 2 hours and administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
Term Neonates
n=3 participants at risk
Pediatric patients (gestational age ≥ 37 weeks), with post-natal age ranging from ≥ 3 days to ≤ 3 months.
Patients were treated with ceftobiprole 10 mg/kg (bodyweight \< 4 kg) or 15mg / kg (bodyweight ≥ 4 kg) infused over 2 hours and administered administered every 12 hours. Ceftobiprole may have been combined with locally-provided ampicillin and/or an aminoglycoside based on the Investigator's judgment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Infections and infestations
Osteomyelitis
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Infections and infestations
Sepsis neonatal
|
16.7%
1/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
General disorders
Oedema
|
33.3%
2/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
0.00%
0/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
|
General disorders
Withdrawal syndrome
|
0.00%
0/6 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
33.3%
1/3 • Up to 5-7 weeks
Adverse event (AE) collection occurred after first study-drug administration, all AEs are considered to be "treatment emergent".
|
Additional Information
Marc Engelhardt, MD, Study Director
Basilea Pharmaceutica International Ltd, Allschwil
Phone: +41 79 701 0551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60