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Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment

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ClinicalTrials.gov Identifier: NCT01688882
Recruitment Status : Terminated (This study was stopped after Part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( >50% better then placebo))
First Posted : September 20, 2012
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bullous Pemphigoid
Interventions Drug: QGE031
Drug: Placebo
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title QGE031 Placebo
Hide Arm/Group Description QGE031 240 mg Q2W s.c. Placebo to Match Q2W s.c.
Period Title: Overall Study
Started 13 7 [1]
Safety Follow-up 11 5
Completed 10 6 [2]
Not Completed 3 1
Reason Not Completed
Adverse Event             1             0
Unsatisfactory therapeutic effect             1             1
Administrative problems             1             0
[1]
4 patients who completed 12 weeks of placebo changed to open-label QGE031 treatment.
[2]
The one patient that discontinued was already switched to open-label QGE031 treatment.
Arm/Group Title QGE031 Placebo Total
Hide Arm/Group Description QGE031 240 mg Q2W s.c. Placebo to Match Q2W s.c. Total of all reporting groups
Overall Number of Baseline Participants 13 7 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 7 participants 20 participants
63.7  (14.85) 67.9  (14.60) 65.2  (14.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
Female
3
  23.1%
4
  57.1%
7
  35.0%
Male
10
  76.9%
3
  42.9%
13
  65.0%
1.Primary Outcome
Title Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12
Hide Description

Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP).

A patient with a CGA-C score of 3 or 4 indicating ‘at least marked improvement from baseline’ at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)

Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set included all randomized patients.
Arm/Group Title QGE031 Placebo
Hide Arm/Group Description:
QGE031 240 mg Q2W s.c.
Placebo to Match Q2W s.c.
Overall Number of Participants Analyzed 13 7
Measure Type: Number
Unit of Measure: number of participants
8 2
2.Secondary Outcome
Title Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks
Hide Description

Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP).

A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)

Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set included all randomized patients.
Arm/Group Title QGE031 Placebo
Hide Arm/Group Description:
QGE031 240 mg Q2W s.c.
Placebo to Match Q2W s.c.
Overall Number of Participants Analyzed 13 7
Measure Type: Number
Unit of Measure: number of participants
8 2
3.Secondary Outcome
Title Number of Patients Investigator Global Assessment Score Over 12 Weeks
Hide Description Investigator’s Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)
Time Frame Baseline (week 0), week 6 and week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set included all randomized patients.
Arm/Group Title QGE031 Placebo
Hide Arm/Group Description:
QGE031 240 mg Q2W s.c.
Placebo to Match Q2W s.c.
Overall Number of Participants Analyzed 13 7
Measure Type: Number
Unit of Measure: Number of participants
Week 0 - IGA Score: 0 0 0
Week 6 - IGA Score: 0 1 2
Week 12 - IGA Score: 0 1 2
Week 0 - IGA Score: 1 0 0
Week 6 - IGA Score: 1 4 2
Week 12 - IGA Score: 1 5 1
Week 0 - IGA Score: 2 0 0
Week 6 - IGA Score: 2 4 0
Week 12 - IGA Score: 2 1 2
Week 0 - IGA Score: 3 4 5
Week 6 - IGA Score: 3 2 2
Week 12 - IGA Score: 3 4 1
Week 0 - IGA Score: 4 9 2
Week 6 - IGA Score: 4 0 0
Week 12- IGA Score: 4 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QGE031 Placebo Open Label QGE031 Follow-up Period: QGE031 Follow-up Period: Placebo Follow-up Period: Open Label QGE031
Hide Arm/Group Description QGE031 240 mg Q2W s.c Placebo to Match Q2W s.c. Open Label QGE031 Q2W s.c. Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c. Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c. Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
All-Cause Mortality
QGE031 Placebo Open Label QGE031 Follow-up Period: QGE031 Follow-up Period: Placebo Follow-up Period: Open Label QGE031
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QGE031 Placebo Open Label QGE031 Follow-up Period: QGE031 Follow-up Period: Placebo Follow-up Period: Open Label QGE031
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/13 (46.15%)   2/7 (28.57%)   1/4 (25.00%)   2/11 (18.18%)   0/5 (0.00%)   0/4 (0.00%) 
Cardiac disorders             
Acute myocardial infarction  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Arrhythmia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Atrial fibrillation  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Cardiac failure  1  0/13 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Cardiogenic shock  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Coronary artery disease  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders             
Gastrointestinal haemorrhage  1  2/13 (15.38%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders             
Hepatic failure  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Infections and infestations             
Pneumonia  1  1/13 (7.69%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Sepsis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Staphylococcal sepsis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Urinary tract infection  1  2/13 (15.38%)  0/7 (0.00%)  0/4 (0.00%)  2/11 (18.18%)  0/5 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications             
Meniscus injury  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders             
Diabetes mellitus  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Hyponatraemia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Nervous system disorders             
Cauda equina syndrome  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Respiratory failure  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders             
Pemphigoid  1  3/13 (23.08%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QGE031 Placebo Open Label QGE031 Follow-up Period: QGE031 Follow-up Period: Placebo Follow-up Period: Open Label QGE031
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/13 (84.62%)   6/7 (85.71%)   2/4 (50.00%)   10/11 (90.91%)   3/5 (60.00%)   2/4 (50.00%) 
Blood and lymphatic system disorders             
Anaemia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Lymphopenia  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Thrombocytosis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Cardiac disorders             
Tachycardia  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Endocrine disorders             
Cushingoid  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Eye disorders             
Conjunctivitis allergic  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Dry eye  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Aphthous stomatitis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorder  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
General disorders             
Asthenia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Chest discomfort  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Injection site haematoma  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Injection site pain  1  0/13 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Malaise  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Xerosis  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/11 (9.09%)  1/5 (20.00%)  0/4 (0.00%) 
Hepatobiliary disorders             
Hepatitis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Immune system disorders             
Drug hypersensitivity  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Infections and infestations             
Acarodermatitis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Cystitis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Furuncle  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Herpes zoster  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Infection  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Nasopharyngitis  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Ophthalmic herpes simplex  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Oral herpes  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Pneumonia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Skin candida  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Urinary tract infection  1  2/13 (15.38%)  1/7 (14.29%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications             
Accidental overdose  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Ligament sprain  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Tooth fracture  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Wound  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Investigations             
Blood lactate dehydrogenase increased  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Blood triglycerides increased  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Eosinophil count increased  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Gamma-glutamyltransferase increased  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Haemoglobin urine present  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Lipase increased  1  2/13 (15.38%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Neutrophil count increased  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Neutrophil morphology abnormal  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Staphylococcus test positive  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
White blood cells urine positive  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders             
Cachexia  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Diabetes mellitus  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Glucose tolerance impaired  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Gout  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Hypercholesterolaemia  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Hyperglycaemia  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Hyperkalaemia  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Hypokalaemia  1  0/13 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Hyponatraemia  1  0/13 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders             
Muscular weakness  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Musculoskeletal stiffness  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Myalgia  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Nervous system disorders             
Burning sensation  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Headache  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Paraesthesia  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Sciatic nerve palsy  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Sciatica  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Syncope  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Vascular dementia  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Psychiatric disorders             
Insomnia  1  2/13 (15.38%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders             
Glycosuria  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders             
Benign prostatic hyperplasia  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Cough  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  1/13 (7.69%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Oropharyngeal pain  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders             
Dry skin  1  1/13 (7.69%)  0/7 (0.00%)  1/4 (25.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Miliaria  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Pemphigoid  1  1/13 (7.69%)  0/7 (0.00%)  1/4 (25.00%)  1/11 (9.09%)  1/5 (20.00%)  1/4 (25.00%) 
Pruritus  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  3/11 (27.27%)  0/5 (0.00%)  0/4 (0.00%) 
Purpura senile  1  0/13 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Skin hyperpigmentation  1  0/13 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Urticaria  1  1/13 (7.69%)  0/7 (0.00%)  0/4 (0.00%)  1/11 (9.09%)  0/5 (0.00%)  0/4 (0.00%) 
Vascular disorders             
Haematoma  1  0/13 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/11 (0.00%)  0/5 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01688882     History of Changes
Other Study ID Numbers: CQGE031X2202
First Submitted: September 17, 2012
First Posted: September 20, 2012
Results First Submitted: March 28, 2016
Results First Posted: April 28, 2016
Last Update Posted: April 28, 2016