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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116168
Recruitment Status : Completed
First Posted : June 28, 2005
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Biological: MEDI-528 0.3 mg/kg
Biological: MEDI-528 1 mg/kg
Biological: MEDI-528 3 mg/kg
Biological: MEDI-528 9 mg/kg
Enrollment 29
Recruitment Details A total of 29 participants provided written informed consent and participated in the study at 2 sites in the United States of America between 10Jun2005 and 18Apr2006.
Pre-assignment Details Eligible participants received MEDI-528 in an open-label manner.
Arm/Group Title MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 6 11 6 6
Completed 0 6 6 6
Not Completed 6 5 0 0
Reason Not Completed
Lost to Follow-up             6             5             0             0
Arm/Group Title MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 11 6 6 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 11 participants 6 participants 6 participants 29 participants
27.2  (8.7) 25.2  (9.7) 34.7  (7.8) 33.2  (13.9) 29.2  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 11 participants 6 participants 6 participants 29 participants
Female
4
  66.7%
4
  36.4%
3
  50.0%
3
  50.0%
14
  48.3%
Male
2
  33.3%
7
  63.6%
3
  50.0%
3
  50.0%
15
  51.7%
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time Frame Days 0 - 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Participants
5 4 6 6
2.Primary Outcome
Title Incidence of Abnormal Troponin Levels
Hide Description Number of participants with troponin levels greater than upper limit of normal
Time Frame Days 0, 1, 7, 14, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
3.Primary Outcome
Title Incidence of Clinically Significant Changes From Baseline in Neurologic Exam
Hide Description Number of participants with clinically significant changes from baseline in neurologic exam
Time Frame Days 0, 7, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
4.Primary Outcome
Title Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain
Hide Description Number of participants with changes from baseline in the Day 28 MRI of the brain
Time Frame Days 0 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 1 1 1
5.Primary Outcome
Title Incidence of Serious Adverse Events
Hide Description Number of participants experiencing serious adverse events
Time Frame Days 0 - 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
6.Secondary Outcome
Title Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Hide Description Number of participants with ADA to MEDI-528
Time Frame Days 0, 14, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 5 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
7.Secondary Outcome
Title Time to Observed Maximum Serum Concentration (Tmax)
Hide Description Tmax of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 4 6 6 6
Mean (Standard Deviation)
Unit of Measure: Days
5.51  (1.90) 4.17  (1.60) 4.50  (1.52) 5.00  (1.90)
8.Secondary Outcome
Title Observed Maximum Serum Concentration (Cmax)
Hide Description Cmax of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 4 6 6 6
Mean (Standard Deviation)
Unit of Measure: Micrograms per milliliter
2.83  (0.73) 14.48  (6.68) 23.00  (5.62) 82.50  (19.64)
9.Secondary Outcome
Title Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Hide Description AUC(0-t) of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 4 6 6 6
Mean (Standard Deviation)
Unit of Measure: Micrograms times day per milliliter
18.47  (10.26) 329.7  (113.72) 923.27  (226.71) 3053.34  (908.30)
10.Secondary Outcome
Title Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528
Hide Description AUC(0-infinity) of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 2 6 6 6
Mean (Standard Deviation)
Unit of Measure: Microgram times day per milliliter
40.78  (0.34) 667.68  (201.99) 1287.31  (413.92) 3770.06  (1396.66)
11.Secondary Outcome
Title Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Hide Description AUC(ext) of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 2 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent
33.32  (6.26) 50.90  (13.82) 26.05  (9.16) 16.61  (8.97)
12.Secondary Outcome
Title Total Body Clearance (CL)
Hide Description CL of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 2 6 6 6
Mean (Standard Deviation)
Unit of Measure: Liter per day
0.49  (0.00) 0.12  (0.05) 0.19  (0.10) 0.20  (0.09)
13.Secondary Outcome
Title Half-life (T1/2)
Hide Description T1/2 of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 2 6 6 6
Mean (Standard Deviation)
Unit of Measure: Days
6.47  (0.85) 86.85  (19.86) 44.43  (11.48) 33.44  (11.32)
14.Secondary Outcome
Title Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)
Hide Description Vz/F of MEDI-528
Time Frame Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.
Arm/Group Title MEDI-528 0.3 mg/kg MEDI-528 1 mg/kg MEDI-528 3 mg/kg MEDI-528 9 mg/kg
Hide Arm/Group Description:
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
MEDI-528 (1 mg/kg) administered as a single, SC dose
MEDI-528 (3 mg/kg) administered as a single, SC dose
MEDI-528 (9 mg/kg) administered as a single, SC dose
Overall Number of Participants Analyzed 2 6 6 6
Mean (Standard Deviation)
Unit of Measure: Liters
4.58  (0.64) 14.57  (8.61) 10.91  (1.21) 8.65  (1.40)
Time Frame Days 0-84
Adverse Event Reporting Description No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
 
Arm/Group Title MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MEDI-528 0.3 mg MEDI-528 1 mg MEDI-528 3 mg MEDI-528 9 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      4/6 (66.67%)      6/6 (100.00%)      6/6 (100.00%)    
Ear and labyrinth disorders         
Ear pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3
Gastrointestinal disorders         
Nausea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Toothache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0
General disorders         
Injection site bruising  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Injection site pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Pyrexia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations         
Ear infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nasopharyngitis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Sinusitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications         
Cartilage injury  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations         
Blood bicarbonate decreased  1  2/6 (33.33%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Blood chloride increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
Blood glucose increased  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Blood sodium decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Blood urea increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Lymph node palpable  1  0/6 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  2 2/6 (33.33%)  4
Protein urine present  1  3/6 (50.00%)  3 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Red blood cells urine positive  1  1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
White blood cell count decreased  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
White blood cell count increased  1  1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders         
Dizziness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dysgeusia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Headache  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2
Sinus headache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Somnolence  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders         
Breast tenderness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Dysmenorrhoea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Haematospermia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Menorrhagia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1
Nasal congestion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Pharyngolaryngeal pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 4/6 (66.67%)  9
Rhinorrhoea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Sinus congestion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Throat irritation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Don Raible, MD
Organization: MedImmune
Phone: 301-398-0000
EMail: raibleD@medimmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00116168    
Other Study ID Numbers: MI-CP109
First Submitted: June 27, 2005
First Posted: June 28, 2005
Results First Submitted: October 17, 2013
Results First Posted: December 11, 2013
Last Update Posted: December 11, 2013