Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma (NCT NCT00507130)
NCT ID: NCT00507130
Last Updated: 2013-12-11
Results Overview
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Days 0 - 150
Results posted on
2013-12-11
Participant Flow
A total of 36 subjects were entered into the study between 28Jun2007 and 17Jul2008 at 8 sites in the United States of America (5 sites) and Canada (3 sites).
Treatment assignments were determined using a block randomization procedure at a 3:1 active treatment-to-placebo ratio through an interactive voice response system (IVRS). When a subject was assigned a Participant Identification Number by the IVRS, the subject was considered randomized into the study.
Participant milestones
| Measure |
PLACEBO
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
PLACEBO
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
SERIOUS EVENT OF ASTHMA EXACERBATION
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma
Baseline characteristics by cohort
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
38.6 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
33.2 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
28.9 Years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
34.7 Years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
9 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Days 0, 14, 28, 56, 84, and 150Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
Number of participants with troponin levels greater than upper limit of normal
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Abnormal Troponin Levels
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days -14 to -1, 14, 28, 56, 84, and 150Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
Number of participants with abnormal clinically significant ECG results
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days -14 to -1 and 28Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
Number of participants experiencing abnormal clinically significant MRI results
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
Number of participants experiencing serious adverse events
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 28, 56, 84, 119, and 150Population: All subjects who received at least one dose of MEDI-528
Number of participants with ADA to MEDI-528
Outcome measures
| Measure |
PLACEBO
n=9 Participants
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150Population: All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis
Tmax of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=8 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Time to Observed Maximum Serum Concentration (Tmax)
|
—
|
3.5 Day
Standard Deviation 2.1
|
3.7 Day
Standard Deviation 2.3
|
3.9 Day
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150Population: All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis
Cmax of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=8 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Observed Maximum Serum Concentration (Cmax)
|
—
|
13.7 Micrograms per milliliter
Standard Deviation 2.7
|
52.1 Micrograms per milliliter
Standard Deviation 33.0
|
105.5 Micrograms per milliliter
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150Population: All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis
T1/2 of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=8 Participants
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 Participants
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 Participants
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Terminal Phase Half-life (T1/2)
|
—
|
37.1 Day
Standard Deviation 7.5
|
35 Day
Standard Deviation 11.5
|
37.7 Day
Standard Deviation 7.5
|
Adverse Events
PLACEBO
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI528 0.3 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI528 1 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI528 3 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=9 participants at risk
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
Other adverse events
| Measure |
PLACEBO
n=9 participants at risk
Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
|
MEDI528 0.3 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 1 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
|
MEDI528 3 mg/kg
n=9 participants at risk
MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 3
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Injection site bruising
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
33.3%
3/9 • Number of events 4
|
|
General disorders
Injection site erythema
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Injection site pain
|
0.00%
0/9
|
33.3%
3/9 • Number of events 3
|
0.00%
0/9
|
33.3%
3/9 • Number of events 8
|
|
General disorders
Injection site swelling
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
|
General disorders
Injection site urticaria
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Influenza
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Nasopharyngitis
|
44.4%
4/9 • Number of events 5
|
33.3%
3/9 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Sinusitis
|
22.2%
2/9 • Number of events 4
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 3
|
22.2%
2/9 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Blood amylase increased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Blood bicarbonate decreased
|
11.1%
1/9 • Number of events 2
|
11.1%
1/9 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
33.3%
3/9 • Number of events 5
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Blood chloride decreased
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Blood chloride increased
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 3
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Blood glucose decreased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Blood glucose increased
|
33.3%
3/9 • Number of events 3
|
55.6%
5/9 • Number of events 8
|
33.3%
3/9 • Number of events 5
|
11.1%
1/9 • Number of events 3
|
|
Investigations
Blood potassium decreased
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Blood potassium increased
|
0.00%
0/9
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Blood urea increased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Blood urine present
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Investigations
False positive laboratory result
|
44.4%
4/9 • Number of events 7
|
22.2%
2/9 • Number of events 3
|
11.1%
1/9 • Number of events 3
|
44.4%
4/9 • Number of events 6
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Lipase increased
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9
|
0.00%
0/9
|
44.4%
4/9 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Neutrophil count increased
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
Protein urine present
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Red blood cells urine positive
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9 • Number of events 5
|
11.1%
1/9 • Number of events 2
|
|
Investigations
White blood cell count increased
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Investigations
White blood cells urine positive
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
22.2%
2/9 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
3/9 • Number of events 3
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
Additional Information
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