Trial Outcomes & Findings for Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions (NCT NCT01466062)
NCT ID: NCT01466062
Last Updated: 2013-06-17
Results Overview
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Day 1 (Screening), Day 31, Day 121
Results posted on
2013-06-17
Participant Flow
Participant milestones
| Measure |
Palivizumab
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Palivizumab
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
Baseline characteristics by cohort
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Age Continuous
|
14.2 months
STANDARD_DEVIATION 6.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Screening), Day 31, Day 121Population: All participants; n=number of non-missing observations.
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Day 1 (Screening); n=28
|
0 µg/mL
Standard Deviation 0
|
|
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Day 31; n=28
|
59.0 µg/mL
Standard Deviation 12.9
|
|
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Day 121; n=26
|
91.8 µg/mL
Standard Deviation 40.6
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.Population: All participants
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
|
0 percentage of participants
Interval 0.0 to 12.3
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.Population: All participants
Percentage of participants who required any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Intensive-care unit
|
0 percentage of participants
Interval 0.0 to 12.3
|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Oxygen supplementation
|
0 percentage of participants
Interval 0.0 to 12.3
|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Mechanical ventilation
|
0 percentage of participants
Interval 0.0 to 12.3
|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Extracorporeal membrane oxygenation
|
0 percentage of participants
Interval 0.0 to 12.3
|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Continuous positive airway pressure
|
0 percentage of participants
Interval 0.0 to 12.3
|
|
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Other mechanical respiratory support
|
0 percentage of participants
Interval 0.0 to 12.3
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.Population: Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.
Number of days of hospitalization caused by RSV infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.Population: Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.
Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit \[ICU\], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.Population: All participants
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any AE
|
27 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any AE leading to death
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Death
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any AE at least "possibly" drug related
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any AE at least "probably not" drug related
|
7 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any "severe" AE
|
2 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any SAE
|
7 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Any AE leading to discontinuation of study drug
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants; n= number of participants with measurements at given time points.
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Baseline Systolic Blood Pressure (SBP); n=26
|
96.1 mm Hg
Standard Deviation 9.44
|
|
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Change from Baseline in SBP at Day 121; n=26
|
-2.4 mm Hg
Standard Deviation 10.23
|
|
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Baseline Diastolic Blood Pressure (DBP); n=25
|
55.0 mm Hg
Standard Deviation 9.16
|
|
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Change from Baseline in DBP at Day 121; n=25
|
3.0 mm Hg
Standard Deviation 14.56
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Outcome measures
| Measure |
Palivizumab
n=26 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
Baseline Body Temperature (BT)
|
36.77 degrees Celcius
Standard Deviation 0.346
|
|
Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
Change from Baseline in BT at Day 12
|
-0.11 degrees Celcius
Standard Deviation 0.400
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Outcome measures
| Measure |
Palivizumab
n=26 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
Baseline Respiratory Rate (RR)
|
33.4 respirations per minute
Standard Deviation 8.59
|
|
Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
Change from Baseline in RR at Day 121
|
1.5 respirations per minute
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Outcome measures
| Measure |
Palivizumab
n=26 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
Baseline Pulse Rate (PR)
|
126.6 beats per minute
Standard Deviation 21.91
|
|
Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
Change from Baseline PR at Day 121
|
-6.7 beats per minute
Standard Deviation 26.66
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Outcome measures
| Measure |
Palivizumab
n=26 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
Baseline Body Weight (BW)
|
8.76 kilograms
Standard Deviation 1.90
|
|
Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
Change from Baseline in BW at Day 121
|
1.23 kilograms
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Normal range for hemoglobin varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=25 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Baseline Hemoglobin
|
11.57 g/dL
Standard Deviation 1.56
|
|
Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Change from Baseline in Hemoglobin at Day 121
|
0.14 g/dL
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Normal range for hematocrit varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=25 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Baseline Hematocrit
|
34.32 percentage of red blood cells
Standard Deviation 4.72
|
|
Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Change from Baseline in Hematocrit at Day 121
|
0.96 percentage of red blood cells
Standard Deviation 5.43
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants; n=number of participants with measurements at given time points.
Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline White Blood Cells (WBC); n=25
|
6.74 cells *10^3/µL
Standard Deviation 3.93
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from Baseline in WBC at Day 121; n=25
|
0.24 cells *10^3/µL
Standard Deviation 2.53
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline (BL) Neutrophils; n=24
|
2.60 cells *10^3/µL
Standard Deviation 2.17
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from BL in Neutrophils at Day 121; n=24
|
-0.05 cells *10^3/µL
Standard Deviation 1.60
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline Eosinophils; n=24
|
0.25 cells *10^3/µL
Standard Deviation 0.26
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from BL in Eosinophils at Day 121; n=24
|
-0.0 cells *10^3/µL
Standard Deviation 0.31
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline Basophils; n=24
|
0.04 cells *10^3/µL
Standard Deviation 0.05
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from Baseline in Basophils at Day 121; n=24
|
0.02 cells *10^3/µL
Standard Deviation 0.07
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline Lymphocytes; n=24
|
3.36 cells *10^3/µL
Standard Deviation 2.35
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from BL in Lymphocytes at Day 121; n=24
|
0.31 cells *10^3/µL
Standard Deviation 1.69
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Baseline Monocytes; n=24
|
0.51 cells *10^3/µL
Standard Deviation 0.44
|
|
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Change from Baseline in Monocytes at Day 121; n=24
|
-0.02 cells *10^3/µL
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Normal ranges for RBC and platelet count varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=25 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Baseline Red Blood Cells (RBC)
|
410.6 cells *10^4/µL
Standard Deviation 70.83
|
|
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Change from Baseline in RBC at Day 121
|
22.3 cells *10^4/µL
Standard Deviation 74.74
|
|
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Baseline Platelet Count
|
31.29 cells *10^4/µL
Standard Deviation 19.80
|
|
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Change from Baseline in Platelet Count at Day 121
|
1.72 cells *10^4/µL
Standard Deviation 18.35
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=24 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Baseline AST
|
39.08 U/L
Standard Deviation 12.95
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Change from Baseline in AST at Day 121
|
1.54 U/L
Standard Deviation 8.09
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Baseline ALT
|
31.13 U/L
Standard Deviation 25.70
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Change from Baseline in ALT at Day 121
|
-3.17 U/L
Standard Deviation 14.07
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Baseline ALP
|
943.0 U/L
Standard Deviation 519.10
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Change from Baseline in ALP at Day 121
|
-18.0 U/L
Standard Deviation 368.35
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 121 (30 days after the 4th dose)Population: All participants with measurements at given time points.
Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.
Outcome measures
| Measure |
Palivizumab
n=24 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Baseline Total Bilirubin
|
0.30 mg/dL
Standard Deviation 0.14
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Change from Baseline in Total Bilirubin at Day 121
|
0.04 mg/dL
Standard Deviation 0.15
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Baseline BUN
|
11.46 mg/dL
Standard Deviation 4.52
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Change from Baseline in BUN at Day 121
|
0.87 mg/dL
Standard Deviation 4.64
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Baseline Creatinine
|
0.23 mg/dL
Standard Deviation 0.04
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Change from Baseline in Creatinine at Day 121
|
0.01 mg/dL
Standard Deviation 0.04
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Baseline CRP
|
0.29 mg/dL
Standard Deviation 0.42
|
|
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Change from Baseline in CRP at Day 121
|
0.03 mg/dL
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Screening, Day 121 (30 days after the 4th dose)Population: All participants; n=number of participants with measurements at given time points.
The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.
Outcome measures
| Measure |
Palivizumab
n=28 Participants
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Protein "-" at Screening; n=24
|
21 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Protein "+/-" at Screening; n=24
|
3 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Protein "-" at Day 121; n=22
|
21 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Protein "+/-" at Day 121; n=22
|
1 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Glucose "-" at Screening; n=24
|
24 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Glucose "-" at Day 121; n=22
|
22 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "-" at Screening; n=24
|
21 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "+/-" at Screening; n=24
|
2 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "1+" at Screening; n=24
|
1 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "-" at Day 121; n=22
|
21 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "+/-" at Day 121; n=22
|
0 participants
|
|
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Occult Blood "1+" at Day 121; n=22
|
1 participants
|
Adverse Events
Palivizumab
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palivizumab
n=28 participants at risk
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Gastrointestinal disorders
Duodenal Stenosis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Bronchitis
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Croup Infectious
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Infectious Peritonitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Pneumonia Bacterial
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Nervous system disorders
Encephalopathy
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Gastroenteritis
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
Other adverse events
| Measure |
Palivizumab
n=28 participants at risk
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
4/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Congenital, familial and genetic disorders
Antithrombin III Deficiency
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Eye disorders
Conjunctivitis
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Rectal Prolapse
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
General disorders
Pyrexia
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
14.3%
4/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
17.9%
5/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Bronchitis
|
14.3%
4/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Conjunctivitis Infective
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Cystitis
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Exanthema Subitum
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Gastroenteritis
|
25.0%
7/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Gastroenteritis Viral
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Impetigo
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Influenza
|
21.4%
6/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Molluscum Contagiosum
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Nasopharyngitis
|
17.9%
5/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Otitis Media
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Otitis Media Acute
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Pharyngitis
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Pseudomonas Infection
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Respiratory Tract Infection
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Rhinitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Rotavirus Infection
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Tinea Cruris
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Tonsillitis
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
35.7%
10/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Infections and infestations
Viral Infection
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
Antithrombin III Decreased
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
Bacterial Test Positive
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
C-Reactive Protein Increased
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
Neutrophil Count Decreased
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
Neutrophil Count Increased
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
White Blood Cell Count Increased
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Investigations
White Blood Cells Urine Positive
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Nervous system disorders
Febrile Convulsion
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Renal and urinary disorders
Azotaemia
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
7.1%
2/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
17.9%
5/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
32.1%
9/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
14.3%
4/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Eczema Infantile
|
10.7%
3/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis Palmaris And Plantaris
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.9%
5/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
4/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER