Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01474538
First received: November 15, 2011
Last updated: February 4, 2014
Last verified: February 2014
Results First Received: February 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin Lispro
Drug: Insulin Aspart

  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
No text entered.

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
Insulin Lispro / Insulin Aspart Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Insulin Aspart / Insulin Lispro Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro  
STARTED     60     62  
Received at Least 1 Dose of Study Drug     60     62  
COMPLETED     57     58  
NOT COMPLETED     3     4  
Death                 1                 0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 3  
Protocol Violation                 0                 1  

Period 2:   Treatment Period 2
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro  
STARTED     57     58  
Received at Least 1 Dose of Study Drug     57     58  
COMPLETED     51     56  
NOT COMPLETED     6     2  
Death                 1                 0  
Adverse Event                 1                 1  
Withdrawal by Subject                 2                 0  
Sponsor decision                 1                 0  
Physician Decision                 0                 1  
Protocol Violation                 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.
All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Insulin Lispro / Insulin Aspart Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Insulin Aspart / Insulin Lispro Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Total Total of all reporting groups

Baseline Measures
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro     Total  
Number of Participants  
[units: participants]
  60     62     122  
Age  
[units: years]
Mean ± Standard Deviation
  58.73  ± 10.41     60.40  ± 9.72     59.58  ± 10.06  
Gender  
[units: participants]
     
Female     33     32     65  
Male     27     30     57  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     5     10  
White     53     54     107  
More than one race     1     1     2  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     58     61     119  
Region of Enrollment  
[units: participants]
     
United States     60     62     122  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycosylated Hemoglobin A1C (HbA1c) at Endpoint   [ Time Frame: After 16 weeks of each treatment (Periods1 and 2) ]

2.  Secondary:   Total Daily Insulin Dose   [ Time Frame: Week 16 of each treatment (Periods 1 and 2) ]

3.  Secondary:   Rate of Hypoglycemic Events Per 30 Days   [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ]

4.  Secondary:   Change From Baseline in Weight   [ Time Frame: Baseline, Week 16 of treatment Periods 1 and 2 ]

5.  Secondary:   Percentage of Participants With Hypoglycemic Events   [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Insulin Lispro Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin Aspart Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Other Adverse Events
    Insulin Lispro     Insulin Aspart  
Total, other (not including serious) adverse events      
# participants affected / at risk     59/118     62/119  
Blood and lymphatic system disorders      
Leukocytosis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Atrial fibrillation † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Atrioventricular block first degree † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Cardiac failure congestive † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Cardiac flutter † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Cardiomyopathy † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Ear and labyrinth disorders      
Eustachian tube dysfunction † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Tinnitus † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Vertigo † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Endocrine disorders      
Hypothyroidism † 1    
# participants affected / at risk     1/118 (0.85%)     2/119 (1.68%)  
# events     1     2  
Eye disorders      
Conjunctivitis † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Iritis † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Lacrimation increased † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Abdominal discomfort † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Abdominal distension † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Diarrhoea † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Nausea † 1    
# participants affected / at risk     5/118 (4.24%)     2/119 (1.68%)  
# events     5     2  
Pancreatitis † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Parotid gland inflammation † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Rectal haemorrhage † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Tongue ulceration † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Tooth impacted † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Vomiting † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
General disorders      
Chest discomfort † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Chest pain † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Facial pain † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Fatigue † 1    
# participants affected / at risk     4/118 (3.39%)     4/119 (3.36%)  
# events     4     4  
Injection site haematoma † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Injection site nodule † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Non-cardiac chest pain † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Oedema † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Oedema peripheral † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Pyrexia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Immune system disorders      
Multiple allergies † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Seasonal allergy † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Infections and infestations      
Bacteraemia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Bronchitis † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Ear infection † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     2  
Fungal infection † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Gastroenteritis viral † 1    
# participants affected / at risk     3/118 (2.54%)     0/119 (0.00%)  
# events     3     0  
Herpes zoster † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Influenza † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Infusion site infection † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Labyrinthitis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Lower respiratory tract infection † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Nasopharyngitis † 1    
# participants affected / at risk     5/118 (4.24%)     5/119 (4.20%)  
# events     5     6  
Onychomycosis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Osteomyelitis † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Pharyngitis streptococcal † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Post procedural infection † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Sepsis † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Sinusitis † 1    
# participants affected / at risk     3/118 (2.54%)     4/119 (3.36%)  
# events     3     4  
Staphylococcal bacteraemia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Staphylococcal infection † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Subcutaneous abscess † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Tooth abscess † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Tooth infection † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Upper respiratory tract infection † 1    
# participants affected / at risk     2/118 (1.69%)     0/119 (0.00%)  
# events     3     0  
Urinary tract infection † 1    
# participants affected / at risk     0/118 (0.00%)     3/119 (2.52%)  
# events     0     3  
Viral infection † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Injury, poisoning and procedural complications      
Arthropod bite † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Contusion † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Fall † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Fibula fracture † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Ligament sprain † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Meniscus lesion † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Muscle strain † 1    
# participants affected / at risk     2/118 (1.69%)     1/119 (0.84%)  
# events     2     1  
Periorbital haematoma † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Post procedural swelling † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Road traffic accident † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Wound † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Investigations      
Angiogram peripheral † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Blood potassium increased † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Blood sodium decreased † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Cardiac murmur † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Catheterisation cardiac † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Glycosylated haemoglobin increased † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
International normalised ratio decreased † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Pulse pressure decreased † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Transaminases increased † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Dyslipidaemia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Hypercholesterolaemia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Hyperlipidaemia † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Vitamin d deficiency † 1    
# participants affected / at risk     0/118 (0.00%)     3/119 (2.52%)  
# events     0     3  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     2     0  
Back pain † 1    
# participants affected / at risk     3/118 (2.54%)     4/119 (3.36%)  
# events     3     4  
Bunion † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Exostosis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Fibromyalgia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Muscle spasms † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Musculoskeletal pain † 1    
# participants affected / at risk     3/118 (2.54%)     3/119 (2.52%)  
# events     3     3  
Osteoarthritis † 1    
# participants affected / at risk     2/118 (1.69%)     1/119 (0.84%)  
# events     2     1  
Pain in extremity † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Rotator cuff syndrome † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Skin cancer † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Skin papilloma † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Thyroid cancer † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Nervous system disorders      
Carotid artery occlusion † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Diabetic neuropathy † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Dizziness † 1    
# participants affected / at risk     2/118 (1.69%)     1/119 (0.84%)  
# events     2     1  
Essential tremor † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Headache † 1    
# participants affected / at risk     0/118 (0.00%)     3/119 (2.52%)  
# events     0     3  
Migraine † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Neuropathy peripheral † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Paraesthesia † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     3/118 (2.54%)     3/119 (2.52%)  
# events     3     3  
Insomnia † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Renal and urinary disorders      
Dysuria † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Incontinence † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Nephrolithiasis † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Pollakiuria † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Renal failure † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Urinary incontinence † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Reproductive system and breast disorders      
Cystocele † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Dysmenorrhoea † 1    
# participants affected / at risk     1/63 (1.59%)     1/64 (1.56%)  
# events     1     2  
Prostatitis † 1    
# participants affected / at risk     1/55 (1.82%)     0/55 (0.00%)  
# events     1     0  
Rectocele † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Uterine prolapse † 1    
# participants affected / at risk     0/63 (0.00%)     1/64 (1.56%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Adenoidal hypertrophy † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Asthma † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Cough † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Dyspnoea † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Dyspnoea exertional † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Epistaxis † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Hypoxia † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Oropharyngeal pain † 1    
# participants affected / at risk     2/118 (1.69%)     1/119 (0.84%)  
# events     2     1  
Pneumonitis † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Pulmonary oedema † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Respiratory tract congestion † 1    
# participants affected / at risk     0/118 (0.00%)     2/119 (1.68%)  
# events     0     2  
Rhinitis allergic † 1    
# participants affected / at risk     1/118 (0.85%)     5/119 (4.20%)  
# events     1     5  
Sinus congestion † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Sneezing † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Throat irritation † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Skin and subcutaneous tissue disorders      
Ecchymosis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Erythema † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Photosensitivity reaction † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Surgical and medical procedures      
Arterial repair † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Coronary angioplasty † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Foraminotomy † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Gastric banding † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Mole excision † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Rotator cuff repair † 1    
# participants affected / at risk     0/118 (0.00%)     1/119 (0.84%)  
# events     0     1  
Spinal fusion surgery † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Spinal laminectomy † 1    
# participants affected / at risk     1/118 (0.85%)     0/119 (0.00%)  
# events     1     0  
Vascular disorders      
Angiopathy † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Deep vein thrombosis † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Flushing † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Hypertension † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Intermittent claudication † 1    
# participants affected / at risk     1/118 (0.85%)     1/119 (0.84%)  
# events     1     1  
Peripheral vascular disorder † 1    
# participants affected / at risk     2/118 (1.69%)     2/119 (1.68%)  
# events     2     2  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.1



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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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