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Trial record 57 of 113 for:    centurion

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

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: NCT01290887
Recruitment Status : Terminated (Business decision)
First Posted : February 7, 2011
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Eosinophilic Asthma
Intervention Drug: Reslizumab
Enrollment 1052
Recruitment Details A total of 1052 patients with eosinophilic asthma at 201 centers in 30 countries were enrolled in this study.
Pre-assignment Details Four hundred-eighty (46%) patients received reslizumab for the first time in Study 3085, having previously received placebo in Studies 3081, 3082, or 3083.
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation
Hide Arm/Group Description The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study. The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Period Title: Overall Study
Started 481 571
Safety Analysis Set 480 [1] 571
Completed 15 [2] 35 [2]
Not Completed 466 536
Reason Not Completed
Adverse Event             6             11
Lack of Efficacy             4             5
Withdrawal by Subject             26             32
Protocol Violation             2             1
Lost to Follow-up             4             4
Non-compliance to study procedures             0             1
Non-compliance to study medications             1             0
Sponsor closure of study             420             476
Not specified             3             6
[1]
One patient was enrolled but not treated.
[2]
Completed study includes completion of the 104 week treatment phase and the 90-day follow-up.
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Total
Hide Arm/Group Description The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study. The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study. Total of all reporting groups
Overall Number of Baseline Participants 481 571 1052
Hide Baseline Analysis Population Description
Enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 481 participants 571 participants 1052 participants
47.4  (14.53) 47.1  (13.58) 47.2  (14.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 481 participants 571 participants 1052 participants
Female
314
  65.3%
332
  58.1%
646
  61.4%
Male
167
  34.7%
239
  41.9%
406
  38.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 481 participants 571 participants 1052 participants
White 371 437 808
Black 22 22 44
Asian 39 48 87
American Indian or Alaskan Native 4 6 10
Pacific Islander 1 1 2
Other 44 57 101
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 481 participants 571 participants 1052 participants
Hispanic or Latino 83 118 201
Non-Hispanic or Latino 187 178 365
Non-Hispanic and non-Latino 208 272 480
Unknown 3 3 6
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 481 participants 571 participants 1052 participants
75.4  (16.67) 76.5  (17.85) 76.0  (17.32)
[1]
Measure Description: n=466, 555,1021
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 481 participants 571 participants 1052 participants
165.3  (10.03) 166.0  (9.96) 165.7  (9.99)
[1]
Measure Description: n=463, 555, 1018
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 481 participants 571 participants 1052 participants
27.6  (5.42) 27.7  (6.04) 27.7  (5.77)
[1]
Measure Description: n=463, 555, 1018
Forced Expiratory Volume in 1 Second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 481 participants 571 participants 1052 participants
2.096  (0.7856) 2.285  (0.8222) 2.199  (0.8108)
% Predicted Expiratory Volume In 1 Second  
Mean (Standard Deviation)
Unit of measure:  Percentage of predicted FEV1
Number Analyzed 481 participants 571 participants 1052 participants
70.739  (19.7560) 75.116  (19.9404) 73.115  (19.9664)
Forced Vital Capacity (FVC)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 481 participants 571 participants 1052 participants
3.163  (1.0357) 3.366  (1.0779) 3.273  (1.0632)
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters/second
Number Analyzed 481 participants 571 participants 1052 participants
1.467  (0.8890) 1.634  (0.9045) 1.558  (0.9009)
[1]
Measure Description: n= 478, 568, 1046
Asthma Control Questionnaire (ACQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 481 participants 571 participants 1052 participants
1.832  (1.0912) 1.450  (0.9870) 1.624  (1.0527)
[1]
Measure Description:

The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.

n= 480, 571, 1051

Asthma Quality of Life Questionnaire (AQLQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 481 participants 571 participants 1052 participants
5.170  (1.2160) 5.496  (1.1431) 5.347  (1.1875)
[1]
Measure Description:

The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses.

n= 476, 569, 1045

Asthma Symptom Utility Index (ASUI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 481 participants 571 participants 1052 participants
0.803  (0.1910) 0.861  (0.1479) 0.832  (0.1728)
[1]
Measure Description:

The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.

n= 186, 191, 377

Blood Eosinophil Count  
Mean (Standard Deviation)
Unit of measure:  10^9 blood eosinophil/L
Number Analyzed 481 participants 571 participants 1052 participants
0.528  (0.3792) 0.078  (0.1480) 0.284  (0.3577)
Used Beta Agonist in Past 3 Days   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 481 participants 571 participants 1052 participants
Yes 300 297 597
No 180 274 454
[1]
Measure Description:

Usage of inhaled corticosteroids/long-acting beta-agonists and usage of oral corticosteroids.

n= 480, 571, 1051

Daily average number of puffs in past 3 days   [1] 
Mean (Standard Deviation)
Unit of measure:  Puffs/day
Number Analyzed 481 participants 571 participants 1052 participants
2.130  (2.4996) 1.568  (2.3982) 1.827  (2.4604)
[1]
Measure Description: n= 475, 554, 1029
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide Description An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
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Hide Analysis Population Description
Safety analysis set
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Measure Type: Number
Unit of Measure: participants
At least 1 AE 359 385 744
Severe AE 31 47 78
Treatment-related AE 49 41 90
AE causing patient discontinuation 6 12 18
Serious AE 33 45 78
Death 1 2 3
AE up to follow-up period 344 367 711
AE during follow-up period 78 82 160
2.Primary Outcome
Title Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
Hide Description

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.

Significance criteria:

  • Blood urea nitrogen: >=10.71 mmol/L
  • Creatinine: >=177 μmol/L
  • Uric acid: M>=625, F>=506 μmol/L
  • Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
  • Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
  • GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.
  • Total bilirubin: >=34.2 μmol/L
  • White blood cells- low: <=3.0*10^9/L
  • White blood cells-high: >=20*10^9/L
  • Hemoglobin: M<=115, F<=95 g/dL
  • Hematocrit: M<0.37, F<0.32 L/L
  • Platelets: >=700*10^9/L
  • Absolute neutrophil count: <=1.0*10^9/L
  • Eosinophils: >=10
  • Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline
Time Frame Weeks 4, 8, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, including participants who contributed to the analysis
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 477 567 1044
Measure Type: Number
Unit of Measure: participants
Blood urea nitrogen 13 10 23
Creatinine 3 2 5
Uric acid 8 5 13
Aspartate aminotransferase 6 5 11
Alanine aminotransferase 7 7 14
GGT 24 15 39
Total bilirubin 3 3 6
White blood cells- low 10 8 18
White blood cells- high 2 1 3
Hemoglobin 10 9 19
Hematocrit 13 13 26
Platelets 1 1 2
Absolute neutrophil count 7 7 14
Eosinophils 24 27 51
Ketones in urine 15 9 24
Blood (hemaglobin) in urine 52 55 107
Glucose in urine 22 32 54
Total protein in urine 71 85 156
3.Primary Outcome
Title Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
Hide Description

Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.

Significance criteria

  • Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)
  • Sitting heart rate-low: <50 and decrease of >=30 beats/min
  • Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)
  • Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)
  • Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)
  • Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)
  • Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)
  • Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)
  • Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)
  • Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)
  • Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)
  • Body temperature-low: <96.5° Fahrenheit (all ages)
  • Body temp-high: >100.5° F (all ages)
Time Frame Week 4 to Week 65
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, including participants who contributed to the analysis
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 478 569 1047
Measure Type: Number
Unit of Measure: participants
Heart rate - high (ages 12-17) 1 2 3
Heart rate - low (ages >=18) 2 1 3
Heart rate - high (ages >=18) 8 8 16
Systolic BP - high (ages 12-17) 0 1 1
Systolic BP - low (ages >=18) 1 0 1
Systolic BP - high (ages >=18) 8 8 16
Diastolic BP - low (ages 12-17) 1 1 2
Diastolic BP - high (ages 12-17) 2 1 3
Diastolic BP - low (ages >=18) 2 4 6
Diastolic - high (ages >=18) 13 12 25
Respiration rate - high (ages 12-17) 0 1 1
Respiration rate - high (ages >=18) 6 2 8
Body temperature - low (ages 12-17) 3 3 6
Body temperature - high (ages 12-17) 0 1 1
Body temperature - low (ages >=18) 102 121 223
Body temperature - high (ages >=18) 3 1 4
4.Secondary Outcome
Title Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.
Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: liters
Week 4 (n=457, 552, 1009) 2.155  (0.7636) 2.277  (0.7999) 2.222  (0.7857)
Week 8 (n=437, 518, 955) 2.162  (0.7966) 2.270  (0.8179) 2.220  (0.8096)
Week 12 (n=426, 499, 925) 2.171  (0.7690) 2.267  (0.8114) 2.223  (0.7932)
Week 16 (n=418, 488, 906) 2.169  (0.7761) 2.267  (0.8101) 2.222  (0.7957)
Week 24 (n=386, 458, 844) 2.188  (0.7966) 2.289  (0.8032) 2.243  (0.8013)
Week 36 (n=291, 354, 645) 2.234  (0.8240) 2.278  (0.8133) 2.258  (0.8178)
Week 48 (n=198, 250, 448) 2.167  (0.7905) 2.336  (0.8189) 2.261  (0.8099)
Week 60 (n=101, 143, 244) 2.234  (0.9214) 2.360  (0.8292) 2.308  (0.8689)
Week 72 (n=56, 105, 161) 2.424  (0.9093) 2.367  (0.8150) 2.387  (0.8466)
Week 84 (n=45, 88, 133) 2.496  (0.8496) 2.384  (0.8411) 2.422  (0.8425)
Week 96 (n=23, 46, 69) 2.748  (0.8963) 2.383  (0.7737) 2.505  (0.8283)
End of study (n=28, 54, 82) 2.505  (0.9386) 2.237  (0.8736) 2.329  (0.8997)
Endpoint (n=478, 569, 1047) 2.174  (0.7798) 2.273  (0.8127) 2.228  (0.7989)
5.Secondary Outcome
Title Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.
Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: percentage of predicted FEV1
Week 4 (n=457, 552, 1009) 73.295  (19.7933) 74.808  (19.1560) 74.123  (19.4521)
Week 8 (n=437, 518, 955) 73.056  (19.9848) 74.765  (20.3570) 73.983  (20.1949)
Week 12 (n=426, 499, 925) 73.797  (19.2586) 74.690  (19.8973) 74.279  (19.6002)
Week 16 (n=418, 488, 906) 73.797  (19.5962) 74.668  (20.2025) 74.266  (19.9188)
Week 24 (n=386, 458, 844) 74.284  (19.5601) 75.208  (19.9621) 74.785  (19.7729)
Week 36 (n=291, 354, 645) 74.805  (20.5634) 75.487  (20.4589) 75.179  (20.4930)
Week 48 (n=198, 250, 448) 73.654  (19.9535) 76.627  (19.8890) 75.313  (19.9500)
Week 60 (n=101, 143, 244) 74.511  (22.5211) 76.613  (20.2416) 75.743  (21.1950)
Week 72 (n=56, 105, 161) 76.856  (20.1821) 76.812  (17.1937) 76.827  (18.2256)
Week 84 (n=45, 88, 133) 79.017  (18.5149) 77.945  (18.4383) 78.308  (18.4011)
Week 96 (n=23, 46, 69) 83.245  (14.9074) 76.746  (16.2345) 78.912  (15.9949)
End of study (n=28, 54, 82) 79.672  (18.6997) 70.633  (20.2554) 73.719  (20.0902)
Endpoint (n=478, 569, 1047) 74.195  (19.8134) 75.107  (19.8530) 74.690  (19.8307)
6.Secondary Outcome
Title Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description

The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.

.

Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: liters
Week 4 (n=457, 552, 1009) 3.222  (0.9929) 3.372  (1.0619) 3.304  (1.0334)
Week 8 (n=437, 518, 955) 3.226  (1.0228) 3.358  (1.0836) 3.297  (1.0577)
Week 12 (n=426, 499, 925) 3.238  (0.9788) 3.339  (1.0584) 3.292  (1.0232)
Week 16 (n=418, 488, 906) 3.238  (0.9949) 3.349  (1.0835) 3.298  (1.0444)
Week 24 (n=386, 458, 844) 3.233  (1.0095) 3.369  (1.0709) 3.307  (1.0449)
Week 36 (n=291, 353, 644) 3.324  (1.0571) 3.346  (1.0416) 3.336  (1.0479)
Week 48 (n=198, 250, 448) 3.229  (1.0334) 3.414  (1.0348) 3.332  (1.0371)
Week 60 (n=101, 143, 244) 3.323  (1.1874) 3.422  (1.0428) 3.381  (1.1037)
Week 72 (n=56, 105, 161) 3.500  (1.1839) 3.398  (1.0795) 3.434  (1.1143)
Week 84 (n=45, 88, 133) 3.606  (1.1403) 3.406  (1.1535) 3.474  (1.1487)
Week 96 (n=23, 46, 69) 3.849  (1.2342) 3.381  (1.1145) 3.537  (1.1680)
End of study (n=28, 54, 82) 3.524  (1.1842) 3.321  (1.2443) 3.390  (1.2206)
Endpoint (n=478, 569, 1047) 3.250  (1.0194) 3.355  (1.0675) 3.307  (1.0466)
7.Secondary Outcome
Title Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description

The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second

.

Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: liters/second
Week 4 (n=446, 545, 991) 1.558  (0.9363) 1.614  (0.9055) 1.589  (0.9195)
Week 8 (n=429, 513, 942) 1.546  (0.9279) 1.618  (0.9255) 1.585  (0.9268)
Week 12 (n=418, 494, 912) 1.587  (0.9833) 1.624  (0.9367) 1.607  (0.9580)
Week 16 (n=408, 483, 891) 1.561  (0.9427) 1.620  (0.9068) 1.593  (0.9234)
Week 24 (n=377, 453, 830) 1.619  (0.9967) 1.637  (0.9227) 1.629  (0.9565)
Week 36 (n=285, 349, 634) 1.642  (1.1087) 1.650  (0.9193) 1.646  (1.0080)
Week 48 (n=191, 249, 440) 1.628  (1.0408) 1.691  (0.9450) 1.664  (0.9871)
Week 60 (n=99, 143, 242) 1.605  (1.0869) 1.791  (1.1508) 1.715  (1.1265)
Week 72 (n=56, 105, 161) 1.810  (1.0239) 1.766  (1.0341) 1.781  (1.0276)
Week 84 (n=45, 88, 133) 1.848  (0.9047) 1.892  (1.1499) 1.877  (1.0700)
Week 96 (n=23, 46, 69) 2.120  (1.0597) 1.942  (1.0453) 2.001  (1.0457)
End of study (n=28, 54, 82) 1.939  (1.1105) 1.639  (0.9079) 1.741  (0.9854)
Endpoint (n=468, 563, 1031) 1.546  (0.9041) 1.629  (0.9300) 1.592  (0.9188)
8.Secondary Outcome
Title Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description

SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.

.

Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: # puffs/day
Week 4 (n=276, 323, 599) 2.5  (2.42) 2.4  (2.45) 2.5  (2.43)
Week 8 (n=258, 302, 560) 2.4  (2.28) 2.4  (2.62) 2.4  (2.46)
Week 12 (n=251, 278, 529) 2.6  (2.07) 2.4  (2.50) 2.5  (2.30)
Week 16 (n=244, 261, 505) 2.5  (2.30) 2.2  (2.29) 2.4  (2.30)
Week 24 (n=211, 243, 454) 2.6  (2.55) 2.3  (2.46) 2.4  (2.51)
Week 36 (n=160, 174, 334) 2.4  (2.27) 2.3  (2.64) 2.3  (2.47)
Week 48 (n=111, 121, 232) 2.2  (2.28) 2.4  (2.54) 2.3  (2.42)
Week 60 (n=50, 64, 114) 2.1  (2.19) 2.5  (3.30) 2.3  (2.86)
Week 72 (n=29, 47, 76) 2.1  (2.19) 1.8  (1.88) 1.9  (1.99)
Week 84 (n=19, 35, 54) 2.0  (1.57) 2.4  (2.38) 2.2  (2.12)
Week 96 (n=14, 26, 40) 1.8  (1.41) 1.7  (1.57) 1.8  (1.50)
End of study (n=16, 23, 39) 2.1  (1.76) 2.7  (1.99) 2.4  (1.90)
Endpoint (n=390, 453, 843) 2.2  (2.20) 2.2  (4.09) 2.2  (3.35)
9.Secondary Outcome
Title Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description

The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.

.

Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 (n=456, 552, 1008) 0.831  (0.1829) 0.844  (0.1631) 0.838  (0.1724)
Week 8 (n=436, 514, 950) 0.843  (0.1663) 0.851  (0.1596) 0.847  (0.1626)
Week 12 (n=426, 500, 926) 0.839  (0.1752) 0.854  (0.1578) 0.847  (0.1661)
Week 16 (n=416, 486, 902) 0.845  (0.1690) 0.856  (0.1659) 0.851  (0.1673)
Week 24 (n=386, 458, 844) 0.844  (0.1720) 0.859  (0.1602) 0.852  (0.1658)
Week 36 (n=291, 354, 645) 0.844  (0.1821) 0.867  (0.1536) 0.857  (0.1673)
Week 48 (n=198, 251, 449) 0.851  (0.1699) 0.856  (0.1705) 0.854  (0.1701)
Week 60 (n=100, 146, 246) 0.869  (0.1573) 0.865  (0.1513) 0.866  (0.1534)
Week 72 (n=56, 105, 161) 0.876  (0.1346) 0.858  (0.1509) 0.865  (0.1453)
Week 84 (n=45, 87, 132) 0.884  (0.1460) 0.868  (0.1541) 0.873  (0.1510)
Week 96 (n=23, 46, 69) 0.822  (0.2036) 0.836  (0.1729) 0.832  (0.1823)
End of study (n=28, 55, 83) 0.877  (0.0979) 0.840  (0.2053) 0.853  (0.1767)
Endpoint (n=478, 569, 1047) 0.843  (0.1679) 0.850  (0.1661) 0.847  (0.1669)
10.Secondary Outcome
Title Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
Hide Description The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.
Time Frame Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 (n=456, 552, 1008) 1.546  (1.0154) 1.429  (0.9573) 1.482  (0.9852)
Week 8 (n=437, 517, 954) 1.446  (0.9805) 1.392  (0.9729) 1.417  (0.9762)
Week 12 (n=426, 500, 926) 1.459  (1.0004) 1.360  (0.9320) 1.405  (0.9648)
Week 16 (n=416, 487, 903) 1.444  (1.0016) 1.305  (0.9299) 1.369  (0.9655)
Week 24 (n=386, 458, 844) 1.436  (1.0135) 1.299  (0.9497) 1.362  (0.9812)
Week 36 (n=291, 353, 644) 1.425  (1.0189) 1.282  (0.9331) 1.347  (0.9746)
Week 48 (n=198, 250, 448) 1.408  (0.9699) 1.297  (0.9810) 1.346  (0.9766)
Week 60 (n=100, 143, 243) 1.284  (0.9739) 1.297  (0.9432) 1.292  (0.9540)
Week 72 (n=56, 105, 161) 1.283  (0.9176) 1.231  (0.8295) 1.249  (0.8587)
Week 84 (n=45, 87, 132) 1.143  (0.9020) 1.209  (0.9186) 1.186  (0.9100)
Week 96 (n=23, 46, 69) 1.323  (0.9862) 1.391  (0.9559) 1.369  (0.9594)
End of study (n=28, 54, 82) 1.061  (0.7653) 1.437  (0.9750) 1.308  (0.9216)
Endpoint (n=478, 569, 1047) 1.450  (0.9901) 1.389  (0.9637) 1.417  (0.9759)
11.Secondary Outcome
Title Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint
Hide Description The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.
Time Frame Weeks 24, 48, 72, 96, End of Study and Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation Reslizumab 3.0 mg/kg
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Overall Number of Participants Analyzed 480 571 1051
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 (n=382, 452, 834) 5.551  (1.1558) 5.691  (1.0651) 5.627  (1.1091)
Week 48 (n=193, 249, 442) 5.602  (1.1180) 5.725  (1.0818) 5.672  (1.0982)
Week 72 (n=56, 106, 162) 5.808  (1.0002) 5.809  (1.0235) 5.809  (1.0124)
Week 96 (n=23, 46, 69) 5.585  (1.1422) 5.809  (1.1340) 5.734  (1.1333)
End of study (n=28, 55, 83) 5.956  (0.9431) 5.765  (1.2361) 5.829  (1.1434)
Endpoint (n=472, 558, 1030) 5.535  (1.1690) 5.631  (1.1334) 5.587  (1.1503)
12.Secondary Outcome
Title Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall
Hide Description

Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.

Predose samples for the reslizumab-experienced participants came from the previous studies.

Time Frame Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set of participants with assessments at stated timeframes
Arm/Group Title Previous Placebo-Treated Subpopulation Previous Reslizumab-Treated Subpopulation
Hide Arm/Group Description:
The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Overall Number of Participants Analyzed 480 571
Measure Type: Number
Unit of Measure: participants
Overall (n=466, 548) 24 25
Baseline (n=442, 541) 16 24
Week 24 (n=382, 445) 12 13
Week 48 (n=187, 247) 9 7
Week 72 (n=56, 104) 4 4
Week 96 (n=24, 48) 3 1
End of study (n=142, 52) 4 1
Endpoint (n=466, 545) 12 17
Time Frame Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reslizumab 3.0 mg/kg
Hide Arm/Group Description Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
All-Cause Mortality
Reslizumab 3.0 mg/kg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reslizumab 3.0 mg/kg
Affected / at Risk (%) # Events
Total   78/1051 (7.42%)    
Cardiac disorders   
Acute myocardial infarction  1  1/1051 (0.10%)  1
Cardiac arrest  1  1/1051 (0.10%)  1
Cardiac failure  1  1/1051 (0.10%)  1
Cardio-respiratory arrest  1  1/1051 (0.10%)  1
Coronary artery occlusion  1  1/1051 (0.10%)  1
Coronary artery stenosis  1  1/1051 (0.10%)  1
Myocardial infarction  1  2/1051 (0.19%)  2
Tachycardia  1  1/1051 (0.10%)  1
Ventricular extrasystoles  1  1/1051 (0.10%)  1
Eye disorders   
Amaurosis fugax  1  1/1051 (0.10%)  1
Gastrointestinal disorders   
Megacolon  1  1/1051 (0.10%)  1
Pancreatitis  1  1/1051 (0.10%)  1
Pneumoperitoneum  1  1/1051 (0.10%)  1
Small intestinal obstruction  1  1/1051 (0.10%)  1
Umbilical hernia  1  1/1051 (0.10%)  1
General disorders   
Adverse drug reaction  1  1/1051 (0.10%)  1
Chest pain  1  1/1051 (0.10%)  1
Hernia  1  1/1051 (0.10%)  1
Suprapubic pain  1  1/1051 (0.10%)  1
Hepatobiliary disorders   
Cholangitis  1  1/1051 (0.10%)  1
Cholecystitis  1  1/1051 (0.10%)  1
Cholelithiasis  1  2/1051 (0.19%)  2
Infections and infestations   
Appendicitis  1  1/1051 (0.10%)  1
Bronchitis pneumococcal  1  1/1051 (0.10%)  1
Cellulitis  1  1/1051 (0.10%)  1
Diverticulitis  1  1/1051 (0.10%)  1
Infectious pleural effusion  1  1/1051 (0.10%)  1
Infective exacerbation of bronchiectasis  1  1/1051 (0.10%)  1
Lower respiratory tract infection  1  1/1051 (0.10%)  1
Mastoiditis  1  1/1051 (0.10%)  1
Otitis media acute  1  1/1051 (0.10%)  1
Peritonitis  1  1/1051 (0.10%)  1
Pneumonia  1  1/1051 (0.10%)  1
Sinusitis  1  1/1051 (0.10%)  1
Upper respiratory tract infection  1  1/1051 (0.10%)  1
Urinary tract infection  1  2/1051 (0.19%)  2
Wound infection  1  1/1051 (0.10%)  1
Injury, poisoning and procedural complications   
Contusion  1  1/1051 (0.10%)  1
Hand fracture  1  1/1051 (0.10%)  1
Hip fracture  1  1/1051 (0.10%)  1
Lower limb fracture  1  1/1051 (0.10%)  1
Skull fractured base  1  1/1051 (0.10%)  1
Spinal compression fracture  1  1/1051 (0.10%)  2
Tibia fracture  1  1/1051 (0.10%)  1
Investigations   
Liver function test abnormal  1  1/1051 (0.10%)  1
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/1051 (0.10%)  1
Gout  1  1/1051 (0.10%)  1
Musculoskeletal and connective tissue disorders   
Osteonecrosis  1  1/1051 (0.10%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anal cancer  1  1/1051 (0.10%)  1
Borderline ovarian tumour  1  1/1051 (0.10%)  1
Breast cancer  1  3/1051 (0.29%)  3
Lymphoma  1  1/1051 (0.10%)  1
Malignant melanoma  1  2/1051 (0.19%)  3
Malignant melanoma in situ  1  1/1051 (0.10%)  1
Metastases to lung  1  1/1051 (0.10%)  1
Ovarian epithelial cancer  1  1/1051 (0.10%)  1
Prostate cancer  1  1/1051 (0.10%)  1
Nervous system disorders   
Carpal tunnel syndrome  1  1/1051 (0.10%)  1
Nervous system disorder  1  1/1051 (0.10%)  1
Transient ischaemic attack  1  1/1051 (0.10%)  1
Psychiatric disorders   
Aggression  1  1/1051 (0.10%)  4
Suicide attempt  1  2/1051 (0.19%)  2
Renal and urinary disorders   
Stress urinary incontinence  1  1/1051 (0.10%)  1
Urethral stenosis  1  1/1051 (0.10%)  2
Reproductive system and breast disorders   
Endometrial hyperplasia  1  1/1051 (0.10%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  18/1051 (1.71%)  24
Asthmatic crisis  1  1/1051 (0.10%)  1
Haemoptysis  1  1/1051 (0.10%)  2
Haemothorax  1  1/1051 (0.10%)  1
Nasal polyps  1  2/1051 (0.19%)  2
Nasal septum deviation  1  1/1051 (0.10%)  1
Pleural effusion  1  1/1051 (0.10%)  1
Pneumonia aspiration  1  1/1051 (0.10%)  1
Skin and subcutaneous tissue disorders   
Actinic keratosis  1  1/1051 (0.10%)  1
Dermatitis atopic  1  1/1051 (0.10%)  1
Drug eruption  1  1/1051 (0.10%)  1
Vascular disorders   
Hypovolaemic shock  1  2/1051 (0.19%)  2
Shock haemorrhagic  1  1/1051 (0.10%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reslizumab 3.0 mg/kg
Affected / at Risk (%) # Events
Total   519/1051 (49.38%)    
Infections and infestations   
Bronchitis  1  62/1051 (5.90%)  77
Nasopharyngitis  1  150/1051 (14.27%)  226
Sinusitis  1  77/1051 (7.33%)  114
Upper respiratory tract infection  1  107/1051 (10.18%)  141
Nervous system disorders   
Headache  1  73/1051 (6.95%)  106
Respiratory, thoracic and mediastinal disorders   
Asthma  1  301/1051 (28.64%)  563
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01290887     History of Changes
Other Study ID Numbers: C38072/3085
2010-024540-15 ( EudraCT Number )
First Submitted: February 4, 2011
First Posted: February 7, 2011
Results First Submitted: March 23, 2016
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016