Trial Outcomes & Findings for STP206 for the Prevention of Necrotizing Enterocolitis (NEC) (NCT NCT01954017)
NCT ID: NCT01954017
Last Updated: 2020-03-24
Results Overview
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
103 participants
Primary outcome timeframe
30 days after the last dose of blinded study treatment
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Low Dose STP206
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
High Dose STP206
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Control
Sterile water
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
33
|
34
|
|
Overall Study
COMPLETED
|
31
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
13
|
Reasons for withdrawal
| Measure |
Low Dose STP206
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
High Dose STP206
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Control
Sterile water
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Death
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
3
|
2
|
|
Overall Study
Necrotizing enterocolitis
|
1
|
0
|
1
|
|
Overall Study
Enteral intake stopped >7 days
|
0
|
1
|
1
|
|
Overall Study
All other reasons
|
2
|
2
|
7
|
Baseline Characteristics
1-minute Apgar scores were not obtained for all subjects.
Baseline characteristics by cohort
| Measure |
Low Dose STP206
n=36 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
High Dose STP206
n=33 Participants
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Control
n=34 Participants
Sterile water
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=28
|
24 Participants
n=36 Participants
|
16 Participants
n=33 Participants
|
23 Participants
n=34 Participants
|
63 Participants
n=103 Participants
|
|
Age, Customized
>28
|
12 Participants
n=36 Participants
|
16 Participants
n=33 Participants
|
10 Participants
n=34 Participants
|
38 Participants
n=103 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=36 Participants
|
12 Participants
n=33 Participants
|
14 Participants
n=34 Participants
|
38 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=36 Participants
|
21 Participants
n=33 Participants
|
20 Participants
n=34 Participants
|
65 Participants
n=103 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=36 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=34 Participants
|
4 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=36 Participants
|
8 Participants
n=33 Participants
|
9 Participants
n=34 Participants
|
28 Participants
n=103 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=36 Participants
|
23 Participants
n=33 Participants
|
23 Participants
n=34 Participants
|
69 Participants
n=103 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=36 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=103 Participants
|
|
1-minute Apgar Score
|
5.1 units on a scale
STANDARD_DEVIATION 2.62 • n=35 Participants • 1-minute Apgar scores were not obtained for all subjects.
|
5.0 units on a scale
STANDARD_DEVIATION 2.04 • n=32 Participants • 1-minute Apgar scores were not obtained for all subjects.
|
4.6 units on a scale
STANDARD_DEVIATION 2.68 • n=33 Participants • 1-minute Apgar scores were not obtained for all subjects.
|
4.9 units on a scale
STANDARD_DEVIATION 2.44 • n=100 Participants • 1-minute Apgar scores were not obtained for all subjects.
|
|
5-minute Apgar Score
|
7.1 units on a scale
STANDARD_DEVIATION 1.95 • n=35 Participants • 5-minute Apgar scores were not obtained for all subjects.
|
7.5 units on a scale
STANDARD_DEVIATION 1.67 • n=32 Participants • 5-minute Apgar scores were not obtained for all subjects.
|
6.9 units on a scale
STANDARD_DEVIATION 2.18 • n=33 Participants • 5-minute Apgar scores were not obtained for all subjects.
|
7.1 units on a scale
STANDARD_DEVIATION 1.93 • n=100 Participants • 5-minute Apgar scores were not obtained for all subjects.
|
|
Birth Weight
|
1110.8 grams
STANDARD_DEVIATION 422.37 • n=35 Participants • Birth weight data were not obtained for all subjects.
|
1110.8 grams
STANDARD_DEVIATION 408.14 • n=32 Participants • Birth weight data were not obtained for all subjects.
|
1141.0 grams
STANDARD_DEVIATION 434.12 • n=33 Participants • Birth weight data were not obtained for all subjects.
|
1120.8 grams
STANDARD_DEVIATION 415.69 • n=100 Participants • Birth weight data were not obtained for all subjects.
|
PRIMARY outcome
Timeframe: 30 days after the last dose of blinded study treatmentPopulation: Safety population
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with at least one treatment-emergent AE
|
7 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with at least one treatment-related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with at least one TEAE Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with at least one related TEAE Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with TEAEs leading to stopping study drug
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Subjects with at least one serious adverse event
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Number of deaths
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days after the last dose of blinded study treatmentPopulation: Safety population
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with at least one treatment-emergent AE
|
5 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with at least one treatment-related TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with at least one TEAE Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with at least one related TEAE Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with TEAEs leading to stopping study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Subjects with at least one serious adverse event
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Number of deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety population
Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Blood: Anaemia neonatal
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Blood: Anaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Blood: Thrombocytopenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Cardiac: Foetal heart rate deceleration
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Cardiac: Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Cardiac: Cardio-respiratory arrest neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Ankyloglossia congenital
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Atrial septal defect
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Patent ductus arteriosus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Cryptorchism
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Endocrine: Hypothyroidism
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Endocrine: Hypopituitarism
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Eye: Conjunctivitis
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Eye: Dacryostenosis acquired
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Eye: Discharge
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: GERD
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Vomiting
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Abdominal distension
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Constipation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Necrotising colitis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Diarrhoea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Haematochezia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Inguinal hernia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: GI perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Ileus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Necrotising enterocolitis neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
General: Hypothermia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
General: Generalised oedema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
General: Infusion site extravasation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
General: Oedema
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Hepatobiliary: Hyperbilirubinaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Hepatobiliary: Cholestasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Nasopharyngitis
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Sepsis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Urinary tract infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Candida infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia klebsiella
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia staphylococcal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Acinetobacter infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial disease carrier
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Endocarditis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Escherichia sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Neonatal pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia escherichia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Upper respiratory tract infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Injury: Rib fracture
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Blood alkaline phosphatase incr
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Lab test abnormal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Blood osmolarity decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Cardiac murmur
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Haematocrit decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Body temperature decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Urine output decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Blood glucose decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Blood osmolarity increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Chest X-ray abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Haematocrit
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Investigations: Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Metabolic acidosis
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hypoalbuminemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Acidosis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Feeding disorder neonatal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hyperphosphataemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hyponatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hyperkalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hypocalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hyperglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hypokalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Glucose tolerance impaired
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Hypernatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Metabolism: Metabolic alkalosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Musculoskeletal: Osteopenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Musculoskeletal: Bone disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Neoplasms: Haemangioma
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Nervous system: Intraventricular haemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Nervous system: Convulsion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Perinatal conditions: Jaundice neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Perinatal conditions: Neonatal disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Renal: Renal failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Renal: Haematuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Renal: Oliguria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Reproductive: Testicular mass
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Apnoea neonatal
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Nasal congestion
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Apnoea
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Aspiration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Bronchopulmonary dysplasia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Neonatal hypoxia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Neonatal respiratory distress syndrom
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Rhinorrhoea
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Pulmonary haemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Acute respiratory distress syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Bronchospasm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Pulmonary oedema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Respiratory disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Skin: Dermatitis diaper
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Skin: Skin discolouration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Skin: Skin disorder
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Skin: Blister
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Skin: Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Vascular: Venous insufficiency
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety population
Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Tachycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: GERD
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Wheezing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Skin: Dermatitis diaper
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Stridor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Skin: Rash
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Skin: Skin discolouration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Skin: Skin disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Vascular: Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Blood: Anaemia neonatal
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Blood: Anaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Blood: Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Blood: Coagulopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Blood: Leukocytosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Foetal heart rate deceleration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Pulmonary valve stenosis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Supraventricuar tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Congenital: Patent ductus arteriosus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Congenital: Adrenogenital syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Congenital: Laryngomalacia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Endocrine: Adrenal insufficiency
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Endocrine: Hypothyroidism
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Endocrine: Diabetes insipidus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Eye: Conjunctivitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Eye: Retinopathy of prematurity
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Eye: Dacryostenosis acquired
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Vomiting
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Abdominal distension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Necrotising colitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Diarrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Flatulence
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Inguinal hernia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Intestinal stenosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Umbilical hernia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
General: Hypothermia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
General: Generalised oedema
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
General: Infusion site extravasation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Hepatobiliary: Hyperbilirubinaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Hepatobiliary: Cholestasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Respiratory syncytial virus infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Urinary tract infection
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Candida infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Pneumonia klebsiella
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Pneumonia staphylococcal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Dacryocystitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Eye infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Fungal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Ophthalmia neonatorum
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Investigations: Blood osmolarity decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Investigations: Haematocrit decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Investigations: Blood sodium decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Investigations: Haemoglobin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Metabolic acidosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypoalbuminemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hyponatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypoglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Enteral feeding intolerance
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hyperkalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypocalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypokalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Late metabolic acidosis of newborn
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Vitamin D deficiency
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypercalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hyperlipidaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hypochloraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Musculoskeletal: Osteopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Musculoskeletal: Bone disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Neoplasms: Haemangioma
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Nervous system: Intraventricular haemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Nervous system: CNS ventriculitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Nervous system: Intraventricular haemorrhage neona
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Nervous system: Convulsion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Renal: Hydronephrosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Renal: Renal disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Renal: Renal failure acute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Apnoea neonatal
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Nasal congestion
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Apnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Bronchopulmonary dysplasia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Neonatal hypoxia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Pulmonary haemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Apparent life threatening event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Pulmonary interstitial emphysema synd
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety
Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: GI perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Cardiac: cardio-respiratory arrest neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Patent ductus arteriosus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Necrotising colitis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Sepsis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Endocarditis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Escherichia sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia escherichia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Pulmonary haemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety
Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Renal: Renal failure acute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Apparent life threatening event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Necrotising colitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Intestinal stenosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Pneumonia staphylococcal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Metabolism: Hyperkalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety
Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Cardiac: Cardio-respiratory arrest neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Congenital: Patent ductus arteriosus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Necrotising colitis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: GI perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
GI: Necrotising enterocolitis neonatal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
General: Hypothermia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Sepsis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Bacterial sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Endocarditis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Escherichia sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia escherichia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Infections: Pneumonia klebsiella
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Nervous system: Convulsion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Respiratory: Pulmonary haemorrhage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days after last administration of study drugPopulation: Safety
Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Renal: Renal failure acute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Respiratory: Apparent life threatening event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Cardiac: Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Congenital: Patent ductus arteriosus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
GI: Necrotising colitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Respiratory syncytial virus infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Staphylococcal sepsis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Infections: Pneumonia staphylococcal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Nervous system: Convulsion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: End of dosing/hospital discharge, up to 781 daysPopulation: Safety
Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Growth Assessment Classification in Low-Dose Treatment Groups
Baseline : Number reporting
|
8 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
Baseline : AGA
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
Baseline : SGA/Head-Spared
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
Baseline : SGA/Symmetric
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
Baseline : LGA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
End of dosing/hx discharge : Number reporting
|
7 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
End of dosing/hx discharge : AGA
|
7 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
End of dosing/hx discharge : SGA/Head-Spared
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
End of dosing/hx discharge : SGA/Symmetric
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Growth Assessment Classification in Low-Dose Treatment Groups
End of dosing/hx discharge : LGA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of dosing/hospital discharge, up to 781 daysPopulation: Safety population
AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Growth Assessment Classification in High-Dose Treatment Groups
Baseline : Number reporting
|
8 participants
|
4 participants
|
7 participants
|
4 participants
|
8 participants
|
4 participants
|
5 participants
|
3 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
Baseline : AGA
|
5 participants
|
4 participants
|
7 participants
|
3 participants
|
4 participants
|
4 participants
|
4 participants
|
3 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
Baseline : SGA/Head-Spared
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
Baseline : SGA/Symmetric
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
Baseline : LGA
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
End of dosing/hx discharge : Number reporting
|
8 participants
|
4 participants
|
7 participants
|
4 participants
|
7 participants
|
4 participants
|
7 participants
|
3 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
End of dosing/hx discharge : AGA
|
7 participants
|
4 participants
|
6 participants
|
4 participants
|
4 participants
|
4 participants
|
1 participants
|
1 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
End of dosing/hx discharge : SGA/Head-Spared
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
End of dosing/hx discharge : SGA/Symmetric
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Growth Assessment Classification in High-Dose Treatment Groups
End of dosing/hx discharge : LGA
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=10 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups
IA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups
IB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=5 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups
IA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups
IB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=10 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
IIA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
IIB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
IIIA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
IIIB
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=5 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
IIA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
IIB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
IIIA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
IIIB
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Sepsis in Low-Dose Treatment Groups
Present
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Sepsis in Low-Dose Treatment Groups
Absent
|
6 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Sepsis in Low-Dose Treatment Groups
Not evaluated
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Sepsis in High-Dose Treatment Groups
Present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Sepsis in High-Dose Treatment Groups
Absent
|
8 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Sepsis in High-Dose Treatment Groups
Not evaluated
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Feeding Intolerance in High-Dose Treatment Groups
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsPopulation: Intent-to-Treat
ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=10 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Any
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Zone 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Zone 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Zone 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Stage 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=5 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Any
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Zone 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Zone 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Zone 3
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Stage 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 5 days to 28 daysIVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=10 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Any
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Grade I
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Grade II
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Grade III
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Grade IV
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 5 days to 28 daysIVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=5 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Any
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Grade I
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Grade II
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Grade III
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Grade IV
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsMild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=10 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Any
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Mild to Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of dosing to 6 monthsMild to Moderate = Need for \< 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first. Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first. For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=5 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Any
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Mild to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 daysPopulation: Safety population
The presence of STP6 and STP11 was assessed in fecal cultures.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=9 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=5 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
Prior to Week 1 Day 4 : STP-6
|
8 participants
|
2 participants
|
7 participants
|
2 participants
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
End of dosing/hx discharge : STP-6
|
6 participants
|
2 participants
|
6 participants
|
0 participants
|
6 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
Prior to Week 1 Day 4 : STP-11
|
4 participants
|
0 participants
|
7 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
End of dosing/hx discharge : STP-11
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 daysPopulation: Safety population
The presence of STP6 and STP11 was assessed in fecal cultures.
Outcome measures
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt: 2000-1501 g) Control
n=4 Participants
Sterile water
|
Group 2a (Birth wt: 1500-1000 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt: 1500-1000 g) Control
n=4 Participants
Sterile water
|
Group 3a (Birth wt: 999-750 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt: 999-750 g) Control
n=4 Participants
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 Participants
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt: 749-500 g) Control
n=4 Participants
Sterile water
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
Prior to Week 1 Day 4 : STP-6
|
8 participants
|
0 participants
|
7 participants
|
1 participants
|
6 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
End of dosing/hx discharge : STP-6
|
3 participants
|
0 participants
|
5 participants
|
0 participants
|
6 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
Prior to Week 1 Day 4 : STP-11
|
8 participants
|
0 participants
|
7 participants
|
0 participants
|
5 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
End of dosing/hx discharge : STP-11
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
5 participants
|
0 participants
|
4 participants
|
0 participants
|
Adverse Events
Group 1a (Birth wt: 2000-1501 g) Low Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 1a (Birth wt:2000-1501 g) Control
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Group 2a (Birth wt:1500-1000 g) Low Dose
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Group 2a (Birth wt:1500-1000 g) Control
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3a (Birth wt:999-750 g) Low Dose
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3a (Birth wt:999-750 g) Control
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4a (Birth wt: 749-500 g) Low Dose
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
Group 4a (Birth wt:749-500 g) Control
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1b (Birth wt: 2000-1501 g) High Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 1b (Birth wt:2000-1501 g) Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2b (Birth wt: 1500-1000 g) High Dose
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2b (Birth wt:1500-1000 g) Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3b (Birth wt: 999-750 g) High Dose
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3b (Birth wt:999-750 g) Control
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4b (Birth wt: 749-500 g) High Dose
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Group 4b (Birth wt:749-500 g) Control
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt:2000-1501 g) Control
n=4 participants at risk
Sterile water
|
Group 2a (Birth wt:1500-1000 g) Low Dose
n=9 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt:1500-1000 g) Control
n=4 participants at risk
Sterile water
|
Group 3a (Birth wt:999-750 g) Low Dose
n=9 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt:999-750 g) Control
n=5 participants at risk
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt:749-500 g) Control
n=4 participants at risk
Sterile water
|
Group 1b (Birth wt: 2000-1501 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 1b (Birth wt:2000-1501 g) Control
n=4 participants at risk
Sterile water
|
Group 2b (Birth wt: 1500-1000 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 2b (Birth wt:1500-1000 g) Control
n=4 participants at risk
Sterile water
|
Group 3b (Birth wt: 999-750 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 3b (Birth wt:999-750 g) Control
n=4 participants at risk
Sterile water
|
Group 4b (Birth wt: 749-500 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 4b (Birth wt:749-500 g) Control
n=4 participants at risk
Sterile water
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Cardio-respiratory arrest neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Patent ductus arterioles
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Necrotising colitis
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Endocarditis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Immune system disorders
Milk allergy
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
Other adverse events
| Measure |
Group 1a (Birth wt: 2000-1501 g) Low Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 1a (Birth wt:2000-1501 g) Control
n=4 participants at risk
Sterile water
|
Group 2a (Birth wt:1500-1000 g) Low Dose
n=9 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 2a (Birth wt:1500-1000 g) Control
n=4 participants at risk
Sterile water
|
Group 3a (Birth wt:999-750 g) Low Dose
n=9 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 3a (Birth wt:999-750 g) Control
n=5 participants at risk
Sterile water
|
Group 4a (Birth wt: 749-500 g) Low Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~1 billion (1 × 10\^9) cfu of STP6 and \~100 million (1 × 10\^8) cfu of STP11 (total of 1.1 billion cfu)
|
Group 4a (Birth wt:749-500 g) Control
n=4 participants at risk
Sterile water
|
Group 1b (Birth wt: 2000-1501 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 1b (Birth wt:2000-1501 g) Control
n=4 participants at risk
Sterile water
|
Group 2b (Birth wt: 1500-1000 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 2b (Birth wt:1500-1000 g) Control
n=4 participants at risk
Sterile water
|
Group 3b (Birth wt: 999-750 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 3b (Birth wt:999-750 g) Control
n=4 participants at risk
Sterile water
|
Group 4b (Birth wt: 749-500 g) High Dose
n=8 participants at risk
Biological
STP206: Live Biotherapeutic
\~ 9 billion (9×10\^9) cfu of STP6 and \~900 million (9 × 10\^8) cfu of STP11 (total of 9.9 billion cfu)
|
Group 4b (Birth wt:749-500 g) Control
n=4 participants at risk
Sterile water
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
40.0%
2/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
55.6%
5/9 • 6 months after last administration of study drug
|
40.0%
2/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
50.0%
4/8 • 6 months after last administration of study drug
|
75.0%
3/4 • 6 months after last administration of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
60.0%
3/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Cardio-respiratory arrest neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Foetal heart rate deceleration
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Eye disorders
Retinopathy of prematurity
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Eye disorders
Eye discharge
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Eye disorders
Strabismus
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
44.4%
4/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Necrotising colitis
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
General disorders
Hypothermia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
General disorders
Generalised oedema
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
General disorders
Infusion site extravasation
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
General disorders
Oedema
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Immune system disorders
Milk allergy
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Endocarditis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Eye infection
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Cardiac murmur
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Haematocrit decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Body temperature decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Urine output decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Blood glucose decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Blood osmolarity increased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Blood sodium decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Haematocrit
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Acidosis
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
33.3%
3/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
50.0%
4/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Enteral feeding intolerance
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Late metabolic acidosis of newborn
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
37.5%
3/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
CNS ventriculitis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
50.0%
2/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Gross motor delay
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
20.0%
1/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
60.0%
3/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dyspasia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
22.2%
2/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
25.0%
2/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Cough
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
25.0%
1/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
|
Renal and urinary disorders
Neonatal hypoxia
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/9 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
11.1%
1/9 • 6 months after last administration of study drug
|
0.00%
0/5 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
12.5%
1/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
0.00%
0/8 • 6 months after last administration of study drug
|
0.00%
0/4 • 6 months after last administration of study drug
|
Additional Information
Scott Rodgers, MS, CCRA, ACRP-PM / Sr Director of Clinical Operations
Leadiant Biosciences, Inc.
Phone: 301-670-1565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60