Trial Outcomes & Findings for A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease (NCT NCT00538785)
NCT ID: NCT00538785
Last Updated: 2012-02-16
Results Overview
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1236 participants
Primary outcome timeframe
Days 0-150
Results posted on
2012-02-16
Participant Flow
A total of 1236 subjects were randomized at 162 sites in 16 countries within the northern hemisphere between 21Oct2005 and 14Dec2005 in Season 1 and 02Oct2007 and 31Dec2007 in Season 2; each subject participated in the study for a single RSV season.
Subjects were randomized 1:1 on Study Day 0 to receive either 15 mg/kg motavizumab or 15 mg/kg palivizumab. A permuted-block randomization method was used and a separate randomization schedule was generated for each site and cyanotic CHD strata combination.
Participant milestones
| Measure |
Motavizumab (MEDI-524)
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Overall Study
STARTED
|
623
|
612
|
|
Overall Study
COMPLETED
|
604
|
595
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
| Measure |
Motavizumab (MEDI-524)
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Overall Study
Death
|
9
|
10
|
|
Overall Study
Withdrawal of consent
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
Baseline characteristics by cohort
| Measure |
Motavizumab (MEDI-524)
n=623 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Total
n=1235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.47 months
STANDARD_DEVIATION 6.40 • n=99 Participants
|
8.18 months
STANDARD_DEVIATION 6.51 • n=107 Participants
|
8.33 months
STANDARD_DEVIATION 6.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=99 Participants
|
298 Participants
n=107 Participants
|
580 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=99 Participants
|
314 Participants
n=107 Participants
|
655 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Non-hispanic
|
540 participants
n=99 Participants
|
529 participants
n=107 Participants
|
1069 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
23 participants
n=99 Participants
|
20 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 participants
n=99 Participants
|
23 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 participants
n=99 Participants
|
32 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=99 Participants
|
146 participants
n=107 Participants
|
301 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=99 Participants
|
26 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Region of Enrollment
Lebanon
|
62 participants
n=99 Participants
|
66 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
67 participants
n=99 Participants
|
65 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
32 participants
n=99 Participants
|
34 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=99 Participants
|
31 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Region of Enrollment
France
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
35 participants
n=99 Participants
|
39 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=99 Participants
|
22 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
28 participants
n=99 Participants
|
26 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
35 participants
n=99 Participants
|
31 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 0-150Population: The Safety population included all subjects who received any study drug and had any safety follow-up.
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=618 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events Through Study Day 150
|
575 participants
|
566 participants
|
PRIMARY outcome
Timeframe: Days 0-150Population: The Safety population included all subjects who received any study drug and had any safety follow-up.
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=618 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events Through Study Day 150
|
292 participants
|
304 participants
|
PRIMARY outcome
Timeframe: Days 0-150Population: Safety population
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=618 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Number of Subjects Reporting Laboratory Adverse Events
Adrenal insufficiency
|
3 participants
|
3 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Alanine aminotranferase increased
|
13 participants
|
26 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Anemia
|
17 participants
|
14 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Aspartate aminotransferase increased
|
3 participants
|
9 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Bacteria sputum indentified
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood alkaline phosphatase increased
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood calcium decreased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood calcium increased
|
2 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood creatinine increased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood potassium decreased
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood potassium increased
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood sodium abnormal
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood sodium decreased
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood thyroid stimulating hormone increased
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Blood urea increased
|
39 participants
|
34 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Brain natriuretic peptide increased
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
C-reactive protein increased
|
0 participants
|
5 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Clostridium difficiline toxin test positive
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Coagulation test abnormal
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Haematocrit drecreased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Haemaglobin decreased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Hepatic enzyme increased
|
3 participants
|
3 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Hyperbilirubinemia
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Hypertransaminasemia
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Hypothyroidism
|
3 participants
|
2 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
International normalised ratio decreased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
International normalised ratio increased
|
0 participants
|
2 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Iron deficiency anaemia
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Liver function test abnormal
|
3 participants
|
2 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Mean cell volume decreased
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Neutropenia
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Occult blood positive
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Oxygen saturation decreased
|
9 participants
|
4 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Platelet count decreased
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Renal function test abnormal
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Thrombocythemia
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Thrombocytopenia
|
1 participants
|
5 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Thyroid function test abnormal
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Transaminases increased
|
0 participants
|
2 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
Urine output decreased
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Laboratory Adverse Events
White blood cell count increased
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-150Population: The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.
An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=623 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
The Number of Subjects Hospitalized for RSV Infection.
|
12 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Days 0-150Population: All subjects who were randomized in Season 2
An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=304 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=310 Participants
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.
|
3 participant
|
6 participant
|
SECONDARY outcome
Timeframe: Days 0-150Population: Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.
ECLA-based method
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=605 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Number of Subjects Who Had Anti-motavizumab Antibodies Detected
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 1Population: Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=543 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentration of Motavizumab at Pre-dose 1
|
0.0 ug/mL
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dose 1Population: Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=521 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1
|
46.90 ug/mL
Standard Deviation 15.20
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dose 2Population: Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=228 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2
|
60.94 ug/mL
Standard Deviation 25.41
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dose 3Population: Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=203 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3
|
66.59 ug/mL
Standard Deviation 34.51
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dose 4Population: Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=203 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4
|
77.87 ug/mL
Standard Deviation 32.75
|
—
|
SECONDARY outcome
Timeframe: Days 0-150Population: Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.
Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.
Outcome measures
| Measure |
Motavizumab (MEDI-524)
n=127 Participants
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass
|
48.51 ug/mL
Standard Deviation 27.30
|
—
|
Adverse Events
Motavizumab (MEDI-524)
Serious events: 292 serious events
Other events: 553 other events
Deaths: 0 deaths
Palivizumab
Serious events: 304 serious events
Other events: 540 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Motavizumab (MEDI-524)
n=618 participants at risk
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 participants at risk
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC ANEURYSM
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/618 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 5 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.81%
5/618 • Number of events 7 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 8 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.16%
1/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 6 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC PSEUDOANEURYSM
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
CYANOSIS
|
1.5%
9/618 • Number of events 9 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 7 • Day 0 - Day 150
|
|
Cardiac disorders
DRESSLER'S SYNDROME
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
MITRAL VALVE STENOSIS
|
0.16%
1/618 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
PULMONARY VALVE STENOSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Cardiac disorders
TACHYCARDIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ANOMALOUS PULMONARY VENOUS CONNECTION
|
0.32%
2/618 • Number of events 5 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
AORTIC VALVE ATRESIA
|
0.16%
1/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.81%
5/618 • Number of events 5 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 3 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
ATRIOVENTRICULAR SEPTAL DEFECT
|
2.1%
13/618 • Number of events 14 • Day 0 - Day 150
|
3.6%
22/612 • Number of events 25 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CHARGE SYNDROME
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CLEFT LIP AND PALATE
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CLEFT PALATE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
COARCTATION OF THE AORTA
|
0.49%
3/618 • Number of events 4 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CONGENITAL AORTIC DILATATION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CONGENITAL CORONARY ARTERY MALFORMATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CONGENITAL MITRAL VALVE STENOSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CONGENITAL PULMONARY VALVE ATRESIA
|
1.3%
8/618 • Number of events 10 • Day 0 - Day 150
|
2.3%
14/612 • Number of events 17 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
CONGENITAL TRICUSPID VALVE ATRESIA
|
1.3%
8/618 • Number of events 11 • Day 0 - Day 150
|
2.0%
12/612 • Number of events 17 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DEVELOPMENTAL GLAUCOMA
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DOUBLE OUTLET RIGHT VENTRICLE
|
1.6%
10/618 • Number of events 12 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 7 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
EBSTEIN'S ANOMALY
|
0.00%
0/618 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
FALLOT'S TETRALOGY
|
6.1%
38/618 • Number of events 45 • Day 0 - Day 150
|
8.0%
49/612 • Number of events 63 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HEART DISEASE CONGENITAL
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 10 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HYPOPLASTIC LEFT HEART SYNDROME
|
2.6%
16/618 • Number of events 23 • Day 0 - Day 150
|
2.9%
18/612 • Number of events 22 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HYPOPLASTIC RIGHT HEART SYNDROME
|
0.32%
2/618 • Number of events 3 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
HYPOSPADIAS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
INTERRUPTION OF AORTIC ARCH
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
MEDIUM-CHAIN ACETYL-COENZYME A DEHYDROGENASE DEFICIENCY
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
MITRAL VALVE ATRESIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
MULTIPLE CARDIAC DEFECTS
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PATENT DUCTUS ARTERIOSUS
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PHIMOSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERY ATRESIA
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PULMONARY SEQUESTRATION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
PYLORIC STENOSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
SCIMITAR SYNDROME
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
SHONE COMPLEX
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
TRANSPOSITION OF THE GREAT VESSELS
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
TRUNCUS ARTERIOSUS PERSISTENT
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
UNIVENTRICULAR HEART
|
1.5%
9/618 • Number of events 10 • Day 0 - Day 150
|
1.8%
11/612 • Number of events 12 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
4.7%
29/618 • Number of events 32 • Day 0 - Day 150
|
5.9%
36/612 • Number of events 38 • Day 0 - Day 150
|
|
Congenital, familial and genetic disorders
DEAFNESS BILATERAL
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Eye disorders
STRABISMUS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTERITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 4 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 8 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INGUINAL HERNIA, OBSTRUCTIVE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
SPIGELIAN HERNIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
VOLVULUS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Gastrointestinal disorders
VOMITING
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 5 • Day 0 - Day 150
|
|
General disorders
CATHETER RELATED COMPLICATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
CYST
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
General disorders
DEATH
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
IRRITABILITY
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
General disorders
PYREXIA
|
0.81%
5/618 • Number of events 6 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 7 • Day 0 - Day 150
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ADENOVIRAL UPPER RESPIRATORY INFECTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
ADENOVIRUS INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHIOLITIS
|
2.4%
15/618 • Number of events 27 • Day 0 - Day 150
|
2.6%
16/612 • Number of events 17 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS
|
1.9%
12/618 • Number of events 16 • Day 0 - Day 150
|
1.6%
10/612 • Number of events 11 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
CROUP INFECTIOUS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
EAR INFECTION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ENDOCARDITIS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ENTEROBACTER BACTERAEMIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS
|
2.8%
17/618 • Number of events 17 • Day 0 - Day 150
|
2.9%
18/612 • Number of events 19 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
1.1%
7/618 • Number of events 7 • Day 0 - Day 150
|
2.3%
14/612 • Number of events 14 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.81%
5/618 • Number of events 5 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
LARYNGITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 4 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
LUNG INFECTION PSEUDOMONAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
MEDIASTINITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
MENINGITIS MENINGOCOCCAL
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
METAPNEUMOVIRUS INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.32%
2/618 • Number of events 3 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA
|
0.81%
5/618 • Number of events 5 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA VIRAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
PHARYNGITIS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA
|
3.2%
20/618 • Number of events 27 • Day 0 - Day 150
|
3.8%
23/612 • Number of events 24 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA ADENOVIRAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 9 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 4 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 4 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
RHINITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
ROTAVIRUS INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
SEPSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
SINUSITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
STAPHYLOCOCCAL MEDIASTINITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
TONSILLITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
TRACHEITIS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.8%
11/618 • Number of events 12 • Day 0 - Day 150
|
1.8%
11/612 • Number of events 12 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION PSEUDOMONAL
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
VARICELLA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL SINUSITIS
|
0.16%
1/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
WOUND INFECTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
AORTIC INJURY
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
POSTPERICARDIOTOMY SYNDROME
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SHUNT MALFUNCTION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SHUNT OCCLUSION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SHUNT STENOSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
CENTRAL VENOUS PRESSURE INCREASED
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Investigations
COAGULATION TEST ABNORMAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Investigations
MEDICAL OBSERVATION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Investigations
SLEEP STUDY
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
DIET REFUSAL
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 5 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FEEDING DISORDER
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
WEIGHT GAIN POOR
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
ANOXIC ENCEPHALOPATHY
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Nervous system disorders
CONVULSION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
FEBRILE CONVULSION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
MYOCLONUS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
PHRENIC NERVE PARALYSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Nervous system disorders
TONIC CLONIC MOVEMENTS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Renal and urinary disorders
PYELOCALIECTASIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ADENOIDAL HYPERTROPHY
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
APNOEA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
APNOEIC ATTACK
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY DYSPLASIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
CHYLOTHORAX
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
DIAPHRAGM MUSCLE WEAKNESS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
DIAPHRAGMATIC HERNIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
DIAPHRAGMATIC PARALYSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL GRANULOMA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERY STENOSIS
|
0.00%
0/618 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 6 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.49%
3/618 • Number of events 4 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSIVE CRISIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY VEIN OCCLUSION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY VEIN STENOSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.65%
4/618 • Number of events 4 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 6 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 5 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEOMALACIA
|
0.00%
0/618 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Surgical and medical procedures
IMMUNISATION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Surgical and medical procedures
URETHRAL MEATOTOMY
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
AORTIC STENOSIS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.00%
0/612 • Day 0 - Day 150
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
THROMBOSIS
|
0.16%
1/618 • Number of events 1 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
|
Vascular disorders
VASOSPASM
|
0.00%
0/618 • Day 0 - Day 150
|
0.16%
1/612 • Number of events 1 • Day 0 - Day 150
|
Other adverse events
| Measure |
Motavizumab (MEDI-524)
n=618 participants at risk
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
Palivizumab
n=612 participants at risk
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.3%
14/618 • Number of events 15 • Day 0 - Day 150
|
2.6%
16/612 • Number of events 22 • Day 0 - Day 150
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.5%
9/618 • Number of events 10 • Day 0 - Day 150
|
1.6%
10/612 • Number of events 10 • Day 0 - Day 150
|
|
Cardiac disorders
CYANOSIS
|
4.0%
25/618 • Number of events 42 • Day 0 - Day 150
|
4.1%
25/612 • Number of events 32 • Day 0 - Day 150
|
|
Eye disorders
CONJUNCTIVITIS
|
6.3%
39/618 • Number of events 42 • Day 0 - Day 150
|
4.4%
27/612 • Number of events 32 • Day 0 - Day 150
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.1%
44/618 • Number of events 47 • Day 0 - Day 150
|
5.1%
31/612 • Number of events 35 • Day 0 - Day 150
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.2%
69/618 • Number of events 80 • Day 0 - Day 150
|
10.5%
64/612 • Number of events 70 • Day 0 - Day 150
|
|
Gastrointestinal disorders
FLATULENCE
|
0.81%
5/618 • Number of events 5 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 7 • Day 0 - Day 150
|
|
Gastrointestinal disorders
ENTERITIS
|
1.1%
7/618 • Number of events 8 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 4 • Day 0 - Day 150
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.1%
19/618 • Number of events 19 • Day 0 - Day 150
|
3.8%
23/612 • Number of events 23 • Day 0 - Day 150
|
|
Gastrointestinal disorders
TEETHING
|
7.1%
44/618 • Number of events 54 • Day 0 - Day 150
|
5.9%
36/612 • Number of events 56 • Day 0 - Day 150
|
|
Gastrointestinal disorders
VOMITING
|
9.5%
59/618 • Number of events 70 • Day 0 - Day 150
|
8.0%
49/612 • Number of events 60 • Day 0 - Day 150
|
|
General disorders
IRRITABILITY
|
3.6%
22/618 • Number of events 33 • Day 0 - Day 150
|
6.0%
37/612 • Number of events 48 • Day 0 - Day 150
|
|
General disorders
PYREXIA
|
29.1%
180/618 • Number of events 285 • Day 0 - Day 150
|
28.9%
177/612 • Number of events 286 • Day 0 - Day 150
|
|
Immune system disorders
IMMUNISATION REACTION
|
0.97%
6/618 • Number of events 8 • Day 0 - Day 150
|
1.3%
8/612 • Number of events 11 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHIOLITIS
|
2.6%
16/618 • Number of events 18 • Day 0 - Day 150
|
1.6%
10/612 • Number of events 11 • Day 0 - Day 150
|
|
Infections and infestations
BRONCHITIS
|
6.5%
40/618 • Number of events 48 • Day 0 - Day 150
|
6.7%
41/612 • Number of events 57 • Day 0 - Day 150
|
|
Infections and infestations
CANDIDIASIS
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 7 • Day 0 - Day 150
|
|
Infections and infestations
CROUP INFECTIOUS
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 9 • Day 0 - Day 150
|
|
Infections and infestations
EAR INFECTION
|
1.5%
9/618 • Number of events 11 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 9 • Day 0 - Day 150
|
|
Infections and infestations
EXANTHEMA SUBITUM
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 7 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS
|
9.1%
56/618 • Number of events 62 • Day 0 - Day 150
|
7.8%
48/612 • Number of events 53 • Day 0 - Day 150
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
1.5%
9/618 • Number of events 9 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 5 • Day 0 - Day 150
|
|
Infections and infestations
INFLUENZA
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.5%
9/618 • Number of events 12 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 13 • Day 0 - Day 150
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.8%
67/618 • Number of events 83 • Day 0 - Day 150
|
9.3%
57/612 • Number of events 79 • Day 0 - Day 150
|
|
Infections and infestations
ORAL CANDIDIASIS
|
1.6%
10/618 • Number of events 10 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 11 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA
|
11.8%
73/618 • Number of events 97 • Day 0 - Day 150
|
11.4%
70/612 • Number of events 95 • Day 0 - Day 150
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
4.2%
26/618 • Number of events 30 • Day 0 - Day 150
|
3.1%
19/612 • Number of events 25 • Day 0 - Day 150
|
|
Infections and infestations
PHARYNGITIS
|
5.0%
31/618 • Number of events 37 • Day 0 - Day 150
|
3.9%
24/612 • Number of events 28 • Day 0 - Day 150
|
|
Infections and infestations
PNEUMONIA
|
1.8%
11/618 • Number of events 12 • Day 0 - Day 150
|
2.1%
13/612 • Number of events 14 • Day 0 - Day 150
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.8%
11/618 • Number of events 12 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 5 • Day 0 - Day 150
|
|
Infections and infestations
RHINITIS
|
14.7%
91/618 • Number of events 115 • Day 0 - Day 150
|
12.6%
77/612 • Number of events 99 • Day 0 - Day 150
|
|
Infections and infestations
SINUSITIS
|
1.6%
10/618 • Number of events 11 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 8 • Day 0 - Day 150
|
|
Infections and infestations
TONSILLITIS
|
2.9%
18/618 • Number of events 21 • Day 0 - Day 150
|
1.3%
8/612 • Number of events 8 • Day 0 - Day 150
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.9%
160/618 • Number of events 235 • Day 0 - Day 150
|
26.8%
164/612 • Number of events 254 • Day 0 - Day 150
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.9%
12/618 • Number of events 13 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 9 • Day 0 - Day 150
|
|
Infections and infestations
VARICELLA
|
1.8%
11/618 • Number of events 11 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 5 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL INFECTION
|
6.1%
38/618 • Number of events 47 • Day 0 - Day 150
|
4.9%
30/612 • Number of events 33 • Day 0 - Day 150
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
1.9%
12/618 • Number of events 13 • Day 0 - Day 150
|
2.5%
15/612 • Number of events 16 • Day 0 - Day 150
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.1%
13/618 • Number of events 13 • Day 0 - Day 150
|
4.1%
25/612 • Number of events 25 • Day 0 - Day 150
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 9 • Day 0 - Day 150
|
|
Investigations
BLOOD UREA INCREASED
|
6.3%
39/618 • Number of events 39 • Day 0 - Day 150
|
5.6%
34/612 • Number of events 35 • Day 0 - Day 150
|
|
Investigations
OXYGEN SATURATION DECREASED
|
1.5%
9/618 • Number of events 10 • Day 0 - Day 150
|
0.65%
4/612 • Number of events 5 • Day 0 - Day 150
|
|
Investigations
WEIGHT DECREASED
|
1.1%
7/618 • Number of events 7 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.65%
4/618 • Number of events 5 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
0.82%
5/612 • Number of events 6 • Day 0 - Day 150
|
|
Psychiatric disorders
RESTLESSNESS
|
0.97%
6/618 • Number of events 7 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.49%
3/618 • Number of events 3 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 7 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.9%
92/618 • Number of events 120 • Day 0 - Day 150
|
11.6%
71/612 • Number of events 95 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
4.2%
26/618 • Number of events 31 • Day 0 - Day 150
|
5.4%
33/612 • Number of events 45 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.5%
9/618 • Number of events 9 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 7 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.32%
2/618 • Number of events 2 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 7 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
3.7%
23/618 • Number of events 27 • Day 0 - Day 150
|
4.6%
28/612 • Number of events 35 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.9%
49/618 • Number of events 64 • Day 0 - Day 150
|
7.4%
45/612 • Number of events 70 • Day 0 - Day 150
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
1.6%
10/618 • Number of events 10 • Day 0 - Day 150
|
1.6%
10/612 • Number of events 12 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
1.1%
7/618 • Number of events 7 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.97%
6/618 • Number of events 7 • Day 0 - Day 150
|
0.49%
3/612 • Number of events 3 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.81%
5/618 • Number of events 5 • Day 0 - Day 150
|
1.1%
7/612 • Number of events 7 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
5.2%
32/618 • Number of events 38 • Day 0 - Day 150
|
5.1%
31/612 • Number of events 38 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.97%
6/618 • Number of events 6 • Day 0 - Day 150
|
0.33%
2/612 • Number of events 2 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
1.8%
11/618 • Number of events 13 • Day 0 - Day 150
|
1.5%
9/612 • Number of events 9 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.4%
27/618 • Number of events 27 • Day 0 - Day 150
|
3.4%
21/612 • Number of events 25 • Day 0 - Day 150
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
1.5%
9/618 • Number of events 10 • Day 0 - Day 150
|
0.98%
6/612 • Number of events 6 • Day 0 - Day 150
|
Additional Information
Pamela Griffin, Senior Director, Clinical Development
MedImmune, LLC
Phone: 301 398 0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER