Trial Outcomes & Findings for Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment (NCT NCT01688882)
NCT ID: NCT01688882
Last Updated: 2016-04-28
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-04-28
Participant Flow
Participant milestones
| Measure |
QGE031
QGE031 240 mg Q2W s.c.
|
Placebo
Placebo to Match Q2W s.c.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
|
Overall Study
Safety Follow-up
|
11
|
5
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
QGE031
QGE031 240 mg Q2W s.c.
|
Placebo
Placebo to Match Q2W s.c.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
1
|
|
Overall Study
Administrative problems
|
1
|
0
|
Baseline Characteristics
Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
Baseline characteristics by cohort
| Measure |
QGE031
n=13 Participants
QGE031 240 mg Q2W s.c.
|
Placebo
n=7 Participants
Placebo to Match Q2W s.c.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 14.60 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 14.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Pharmacodynamics (PD) analysis set included all randomized patients.
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)
Outcome measures
| Measure |
QGE031
n=13 Participants
QGE031 240 mg Q2W s.c.
|
Placebo
n=7 Participants
Placebo to Match Q2W s.c.
|
|---|---|---|
|
Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12
|
8 number of participants
|
2 number of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Pharmacodynamics (PD) analysis set included all randomized patients.
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)
Outcome measures
| Measure |
QGE031
n=13 Participants
QGE031 240 mg Q2W s.c.
|
Placebo
n=7 Participants
Placebo to Match Q2W s.c.
|
|---|---|---|
|
Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks
|
8 number of participants
|
2 number of participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 6 and week 12Population: Pharmacodynamics (PD) analysis set included all randomized patients.
Investigator's Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)
Outcome measures
| Measure |
QGE031
n=13 Participants
QGE031 240 mg Q2W s.c.
|
Placebo
n=7 Participants
Placebo to Match Q2W s.c.
|
|---|---|---|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 0 - IGA Score: 0
|
0 Number of participants
|
0 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 6 - IGA Score: 0
|
1 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 12 - IGA Score: 0
|
1 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 0 - IGA Score: 1
|
0 Number of participants
|
0 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 6 - IGA Score: 1
|
4 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 12 - IGA Score: 1
|
5 Number of participants
|
1 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 0 - IGA Score: 2
|
0 Number of participants
|
0 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 6 - IGA Score: 2
|
4 Number of participants
|
0 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 12 - IGA Score: 2
|
1 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 0 - IGA Score: 3
|
4 Number of participants
|
5 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 12 - IGA Score: 3
|
4 Number of participants
|
1 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 0 - IGA Score: 4
|
9 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 6 - IGA Score: 4
|
0 Number of participants
|
0 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 6 - IGA Score: 3
|
2 Number of participants
|
2 Number of participants
|
|
Number of Patients Investigator Global Assessment Score Over 12 Weeks
Week 12- IGA Score: 4
|
0 Number of participants
|
0 Number of participants
|
Adverse Events
QGE031
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Open Label QGE031
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Follow-up Period: QGE031
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Follow-up Period: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Follow-up Period: Open Label QGE031
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QGE031
n=13 participants at risk
QGE031 240 mg Q2W s.c
|
Placebo
n=7 participants at risk
Placebo to Match Q2W s.c.
|
Open Label QGE031
n=4 participants at risk
Open Label QGE031 Q2W s.c.
|
Follow-up Period: QGE031
n=11 participants at risk
Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
|
Follow-up Period: Placebo
n=5 participants at risk
Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
|
Follow-up Period: Open Label QGE031
n=4 participants at risk
Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Arrhythmia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/13
|
14.3%
1/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Cardiogenic shock
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Coronary artery disease
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
15.4%
2/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Hepatobiliary disorders
Hepatic failure
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Sepsis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Staphylococcal sepsis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13
|
0.00%
0/7
|
0.00%
0/4
|
18.2%
2/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Cauda equina syndrome
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
23.1%
3/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
Other adverse events
| Measure |
QGE031
n=13 participants at risk
QGE031 240 mg Q2W s.c
|
Placebo
n=7 participants at risk
Placebo to Match Q2W s.c.
|
Open Label QGE031
n=4 participants at risk
Open Label QGE031 Q2W s.c.
|
Follow-up Period: QGE031
n=11 participants at risk
Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
|
Follow-up Period: Placebo
n=5 participants at risk
Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
|
Follow-up Period: Open Label QGE031
n=4 participants at risk
Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Endocrine disorders
Cushingoid
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Eye disorders
Conjunctivitis allergic
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Eye disorders
Dry eye
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Asthenia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Chest discomfort
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Injection site haematoma
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site pain
|
0.00%
0/13
|
14.3%
1/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Malaise
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Xerosis
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
9.1%
1/11
|
20.0%
1/5
|
0.00%
0/4
|
|
Hepatobiliary disorders
Hepatitis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Immune system disorders
Drug hypersensitivity
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Acarodermatitis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Cystitis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Furuncle
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
25.0%
1/4
|
|
Infections and infestations
Infection
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Ophthalmic herpes simplex
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Skin candida
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13
|
14.3%
1/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Eosinophil count increased
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Haemoglobin urine present
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Lipase increased
|
15.4%
2/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Neutrophil count increased
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Neutrophil morphology abnormal
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
Staphylococcus test positive
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Investigations
White blood cells urine positive
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Cachexia
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
20.0%
1/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13
|
14.3%
1/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13
|
14.3%
1/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Burning sensation
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Sciatic nerve palsy
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Sciatica
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
20.0%
1/5
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Renal and urinary disorders
Glycosuria
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13
|
0.00%
0/7
|
25.0%
1/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
7.7%
1/13
|
0.00%
0/7
|
25.0%
1/4
|
9.1%
1/11
|
20.0%
1/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
27.3%
3/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/13
|
14.3%
1/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
1/11
|
0.00%
0/5
|
0.00%
0/4
|
|
Vascular disorders
Haematoma
|
0.00%
0/13
|
0.00%
0/7
|
25.0%
1/4
|
0.00%
0/11
|
0.00%
0/5
|
0.00%
0/4
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER