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HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00349349
First received: July 6, 2006
Last updated: May 29, 2014
Last verified: June 2013
Results First Received: October 20, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukaemia, Lymphocytic, Chronic
Intervention: Drug: ofatumumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
2000 mg Ofatumumab + DR Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.

Participant Flow:   Overall Study
    2000 mg Ofatumumab + DR   2000 mg Ofatumumab + BFR   2000 mg Ofatumumab + Other
STARTED   95   112   16 
COMPLETED   42   50   10 
NOT COMPLETED   53   62   6 
Adverse Event                5                6                2 
Withdrawal by Subject                5                2                1 
Withdrawn due to Disease Progression                27                37                1 
Death                13                10                1 
Other Treatment Selected                2                0                0 
Participant Reduced General Condition                0                1                0 
Physician Decision                1                2                1 
No Response                0                3                0 
New Malignancy (Bladder Cancer)                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
2000 mg Ofatumumab + DR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other,"defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.
Total Total of all reporting groups

Baseline Measures
   2000 mg Ofatumumab + DR   2000 mg Ofatumumab + BFR   2000 mg Ofatumumab + Other   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   112   16   223 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (8.4)   64.4  (9.3)   64.5  (7.4)   63.9  (8.8) 
Gender 
[Units: Participants]
       
Female   24   31   5   60 
Male   71   81   11   163 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   1   0   1   2 
Black or African American   2   1   0   3 
Hispanic or Latino   1   0   0   1 
White   88   111   15   214 
Arab   1   0   0   1 
Yemenite   1   0   0   1 
Middle Eastern   1   0   0   1 


  Outcome Measures
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1.  Primary:   Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

2.  Secondary:   Duration of Response   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24 ]

4.  Secondary:   Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment   [ Time Frame: Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months]) ]

5.  Secondary:   Overall Survival   [ Time Frame: Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks) ]

6.  Secondary:   Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts   [ Time Frame: Baseline (Visit 2) until Week 7 (Visit 9) ]

7.  Secondary:   Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts   [ Time Frame: Baseline (Visit 2) until Week 7 (Visit 9) ]

8.  Secondary:   Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)   [ Time Frame: Baseline (Visit 2) until Week 24 (Visit 14) ]

9.  Secondary:   Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24   [ Time Frame: Baseline (Visit 2) and Week 24 ]

10.  Secondary:   Number of Participants With Complete Resolution of Lymphadenopathy   [ Time Frame: Baseline (Visit 2) to end of study (up to Week 24) ]

11.  Secondary:   Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24   [ Time Frame: Baseline (Visit 2) and Week 24 ]

12.  Secondary:   Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening   [ Time Frame: Screening (Visit 1, <=14 days prior to Visit 2) ]

13.  Secondary:   Number of Participants With Improvement in Hemoglobin   [ Time Frame: Baseline (Visit 2) to Week 28 ]

14.  Secondary:   Number of Participants With Improvement in Thrombocytopenia (Thromb.)   [ Time Frame: Baseline (Visit 2) to Week 28 ]

15.  Secondary:   Number of Participants With Complete Resolution of Hepatomegaly   [ Time Frame: Baseline (Visit 2) until Week 24 ]

16.  Secondary:   Number of Participants With Improvement in Neutropenia   [ Time Frame: Baseline (Visit 2) to Week 28 ]

17.  Secondary:   Number of Participants With Complete Resolution of Splenomegaly   [ Time Frame: Baseline (Visit 2) until Week 24 ]

18.  Secondary:   Number of Participants Who Experienced Any Adverse Event   [ Time Frame: From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up) ]

19.  Secondary:   Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24) ]

20.  Secondary:   AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]

21.  Secondary:   Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit14 (Week 24) ]

22.  Secondary:   Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]

23.  Secondary:   Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)   [ Time Frame: Visit 9 (Week 7) and Visit 14 (Week 24) ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
2000 mg Ofatumumab + DR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
2000 mg Ofatumumab + BFR Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
2000 mg Ofatumumab + Other Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as "other,"defined as participants who were enrolled in the study but did not meet criteria for DR or BFR.

Serious Adverse Events
    2000 mg Ofatumumab + DR   2000 mg Ofatumumab + BFR   2000 mg Ofatumumab + Other
Total, serious adverse events       
# participants affected / at risk   60/95 (63.16%)   59/112 (52.68%)   12/16 (75.00%) 
Blood and lymphatic system disorders       
Neutropenia † 1       
# participants affected / at risk   7/95 (7.37%)   3/112 (2.68%)   3/16 (18.75%) 
Febrile neutropenia † 1       
# participants affected / at risk   2/95 (2.11%)   3/112 (2.68%)   1/16 (6.25%) 
Hemolytic anaemia † 1       
# participants affected / at risk   0/95 (0.00%)   2/112 (1.79%)   0/16 (0.00%) 
Agranulocytosis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Anemia † 1       
# participants affected / at risk   2/95 (2.11%)   1/112 (0.89%)   0/16 (0.00%) 
Anemia haemolytic autoimmune † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Lymphocytic infiltration † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Thrombocytopenia † 1       
# participants affected / at risk   4/95 (4.21%)   1/112 (0.89%)   0/16 (0.00%) 
Cardiac disorders       
Myocardial infarction † 1       
# participants affected / at risk   1/95 (1.05%)   2/112 (1.79%)   0/16 (0.00%) 
Myocardial ischaemia † 1       
# participants affected / at risk   0/95 (0.00%)   2/112 (1.79%)   0/16 (0.00%) 
Cardic failure † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Myopericarditis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Cardiac arrest † 1       
# participants affected / at risk   0/95 (0.00%)   2/112 (1.79%)   0/16 (0.00%) 
Ear and labyrinth disorders       
Vertigo † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Eye disorders       
Diplopia † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Gastrointestinal disorders       
Small intestinal obstruction † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Enteritis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Ascites † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Abdominal pain † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Constipation † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Diarrhea † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Gastrointestinal pain † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
General disorders       
Disease progression † 1       
# participants affected / at risk   4/95 (4.21%)   5/112 (4.46%)   1/16 (6.25%) 
Pyrexia † 1       
# participants affected / at risk   6/95 (6.32%)   4/112 (3.57%)   0/16 (0.00%) 
Hyperthermia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Infusion related reaction † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Immune system disorders       
Cytokine release syndrome † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Hypersensitivity † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Contrast media allergy † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Immunodeficiency † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Infections and infestations       
Pneumonia † 1       
# participants affected / at risk   12/95 (12.63%)   12/112 (10.71%)   2/16 (12.50%) 
Sepsis † 1       
# participants affected / at risk   5/95 (5.26%)   6/112 (5.36%)   0/16 (0.00%) 
Bronchopneumonia † 1       
# participants affected / at risk   2/95 (2.11%)   1/112 (0.89%)   0/16 (0.00%) 
Herpes zoster † 1       
# participants affected / at risk   2/95 (2.11%)   1/112 (0.89%)   0/16 (0.00%) 
Neutropenic sepsis † 1       
# participants affected / at risk   4/95 (4.21%)   0/112 (0.00%)   1/16 (6.25%) 
Sinusitis † 1       
# participants affected / at risk   2/95 (2.11%)   2/112 (1.79%)   0/16 (0.00%) 
Urinary tract infection † 1       
# participants affected / at risk   2/95 (2.11%)   2/112 (1.79%)   0/16 (0.00%) 
Bronchitis † 1       
# participants affected / at risk   2/95 (2.11%)   0/112 (0.00%)   0/16 (0.00%) 
Septic shock † 1       
# participants affected / at risk   3/95 (3.16%)   0/112 (0.00%)   0/16 (0.00%) 
Lobar pneumonia † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Appendicitis † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Aspergilloma † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Cellulitis † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Enterocolitis infection † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Folliculitis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Fusarium infection † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Gastroenteritis † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Infection † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Injection site infection † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Lung infection † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Peritoneal infection † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Pneumocystis jiroveci pneumonia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Pneumonia fungal † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Progessive multifocal † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Pseudomonas infection † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Upper respiratory tract infection † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Lower respiration infection † 1       
# participants affected / at risk   0/95 (0.00%)   2/112 (1.79%)   0/16 (0.00%) 
Ear infection † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Eczema infected † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Erysipelas † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Enterocolitis infections † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Escherichia sepsis † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Eye infection staphylococcal † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Influenza † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Nocardiosis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Pseuromonas infection † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Respiratory tract infection † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Accidental overdose † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Postoperative fever † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Transfusion reaction † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Lower limb fracture † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Spinal compression fracture † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Investigations       
Blood lactate dehydrogenase increased † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Neutrophil count decreased † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Blood uric acid increased † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Hypercalcaemia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Diabetes † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Hypokalemia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Arthralgia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Bone pain † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer † 1       
# participants affected / at risk   1/95 (1.05%)   1/112 (0.89%)   0/16 (0.00%) 
Chronic lympocytic leukaemia † 1       
# participants affected / at risk   1/95 (1.05%)   3/112 (2.68%)   0/16 (0.00%) 
Hodgkins disease † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Mantle cell lymphoma † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Chronic lymphocytic leukaemia transformation † 1       
# participants affected / at risk   2/95 (2.11%)   0/112 (0.00%)   0/16 (0.00%) 
Bladder cancer † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Bowen's disease † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Colon cancer † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Neoplasm † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Skin cancer † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Squamous cell carcinoma of the skin † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Tumor lysis syndrome † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Nervous system disorders       
Facial paresis † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Hemiparesis † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Ischaemic stroke † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Transient ischaemic attack † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Cerebral ischemia † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Epilepsy † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Psychiatric disorders       
Confusional state † 1       
# participants affected / at risk   2/95 (2.11%)   0/112 (0.00%)   0/16 (0.00%) 
Renal and urinary disorders       
Urinary retention † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Haemoptysis † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Hypoxia † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Pleural effusion † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   1/16 (6.25%) 
Pulmonary embolism † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Pulmonary edema † 1       
# participants affected / at risk   0/95 (0.00%)   2/112 (1.79%)   0/16 (0.00%) 
Acute repiratory failure † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Bronchospasm † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Dyspnea † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Lung disorder † 1       
# participants affected / at risk   0/95 (0.00%)   1/112 (0.89%)   0/16 (0.00%) 
Lung infiltration † 1       
# participants affected / at risk   0/95 (0.00%)   0/112 (0.00%)   1/16 (6.25%) 
Respiratory failure † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Pyroderma gangrenosum † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Rash † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Vascular disorders       
Deep vein thrombosis † 1       
# participants affected / at risk   1/95 (1.05%)   2/112 (1.79%)   0/16 (0.00%) 
Haematoma † 1       
# participants affected / at risk   1/95 (1.05%)   0/112 (0.00%)   0/16 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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