Trial Outcomes & Findings for Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes (NCT NCT00971243)
NCT ID: NCT00971243
Last Updated: 2026-01-07
Results Overview
The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
448 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Teneli 5mg+Met
Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 10mg+Met
Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 20mg+Met
Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 40mg+Met
Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Placebo+Met
Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
|---|---|---|---|---|---|
|
Double Blind Period
STARTED
|
87
|
93
|
91
|
88
|
88
|
|
Double Blind Period
COMPLETED
|
68
|
82
|
72
|
74
|
70
|
|
Double Blind Period
NOT COMPLETED
|
19
|
11
|
19
|
14
|
18
|
|
Open-label Period
STARTED
|
68
|
81
|
71
|
74
|
70
|
|
Open-label Period
COMPLETED
|
60
|
71
|
66
|
64
|
64
|
|
Open-label Period
NOT COMPLETED
|
8
|
10
|
5
|
10
|
6
|
Reasons for withdrawal
| Measure |
Teneli 5mg+Met
Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 10mg+Met
Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 20mg+Met
Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 40mg+Met
Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Placebo+Met
Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
|---|---|---|---|---|---|
|
Double Blind Period
Adverse Event
|
2
|
3
|
2
|
2
|
3
|
|
Double Blind Period
Lost to Follow-up
|
0
|
1
|
1
|
0
|
1
|
|
Double Blind Period
Physician Decision
|
10
|
6
|
7
|
6
|
7
|
|
Double Blind Period
Protocol Violation
|
2
|
0
|
3
|
2
|
2
|
|
Double Blind Period
Withdrawal by Subject
|
4
|
1
|
4
|
4
|
4
|
|
Double Blind Period
Other reasons
|
1
|
0
|
2
|
0
|
1
|
|
Open-label Period
Adverse Event
|
1
|
0
|
1
|
1
|
0
|
|
Open-label Period
Physician Decision
|
5
|
9
|
3
|
7
|
2
|
|
Open-label Period
Protocol Violation
|
1
|
1
|
1
|
0
|
1
|
|
Open-label Period
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
1
|
|
Open-label Period
Other reason
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Teneli 5mg+Met
n=87 Participants
Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 10mg+Met
n=93 Participants
Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 20mg+Met
n=91 Participants
Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 40mg+Met
n=88 Participants
Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Placebo+Met
n=88 Participants
Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 7.7 • n=37 Participants
|
58.5 years
STANDARD_DEVIATION 8.4 • n=56 Participants
|
58.3 years
STANDARD_DEVIATION 9.5 • n=95 Participants
|
58.2 years
STANDARD_DEVIATION 8.6 • n=61 Participants
|
58.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 8.5 • n=25 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=37 Participants
|
42 Participants
n=56 Participants
|
35 Participants
n=95 Participants
|
36 Participants
n=61 Participants
|
41 Participants
n=5 Participants
|
195 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=37 Participants
|
51 Participants
n=56 Participants
|
56 Participants
n=95 Participants
|
52 Participants
n=61 Participants
|
47 Participants
n=5 Participants
|
252 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.
The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.
Outcome measures
| Measure |
Teneli 5mg+Met
n=87 Participants
Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 10mg+Met
n=93 Participants
Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 20mg+Met
n=91 Participants
Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 40mg+Met
n=88 Participants
Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Placebo+Met
n=88 Participants
Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
|---|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 24
|
-0.58 percentage of HbA1c
Standard Error 0.07
|
-0.68 percentage of HbA1c
Standard Error 0.07
|
-0.76 percentage of HbA1c
Standard Error 0.07
|
-0.91 percentage of HbA1c
Standard Error 0.07
|
-0.28 percentage of HbA1c
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.
Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.
Outcome measures
| Measure |
Teneli 5mg+Met
n=87 Participants
Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 10mg+Met
n=93 Participants
Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 20mg+Met
n=91 Participants
Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Teneli 40mg+Met
n=88 Participants
Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
Placebo+Met
n=88 Participants
Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
|
|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
|
-15.54 mg/dL
Standard Error 2.94
|
-13.65 mg/dL
Standard Error 2.83
|
-17.84 mg/dL
Standard Error 2.86
|
-21.85 mg/dL
Standard Error 2.91
|
-3.51 mg/dL
Standard Error 2.95
|
SECONDARY outcome
Timeframe: Weeks 24, 52Outcome measures
Outcome data not reported
Adverse Events
Teneli 5mg+Met
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Teneli 10 mg+Met
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Teneli 20 mg+Met
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Teneli 40 mg+Met
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo+Met
Serious events: 6 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teneli 5mg+Met
n=87 participants at risk
Teneligliptin 5mg plus Metformin
|
Teneli 10 mg+Met
n=93 participants at risk
Teneligliptin 10mg plus Metformin
|
Teneli 20 mg+Met
n=91 participants at risk
Teneligliptin 20mg plus Metformin
|
Teneli 40 mg+Met
n=88 participants at risk
Teneligliptin 40mg plus Metformin
|
Placebo+Met
n=88 participants at risk
Placebo plus Metformin
|
|---|---|---|---|---|---|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
PNEUMONIA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
IIIRD NERVE PARALYSIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Hepatobiliary disorders
FATTY LIVER ALCOHOLIC
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
Other adverse events
| Measure |
Teneli 5mg+Met
n=87 participants at risk
Teneligliptin 5mg plus Metformin
|
Teneli 10 mg+Met
n=93 participants at risk
Teneligliptin 10mg plus Metformin
|
Teneli 20 mg+Met
n=91 participants at risk
Teneligliptin 20mg plus Metformin
|
Teneli 40 mg+Met
n=88 participants at risk
Teneligliptin 40mg plus Metformin
|
Placebo+Met
n=88 participants at risk
Placebo plus Metformin
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
VASOMOTOR RHINITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.3%
2/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
5.5%
5/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
3.4%
3/88 • 24 weeks
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Gastrointestinal disorders
REFLUX OESOPHAGITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
VOMITING
|
1.1%
1/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Gastrointestinal disorders
APICAL GRANULOMA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS SARCOIDOSIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
PHOTODERMATOSIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
HAEMARTHROSIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Renal and urinary disorders
GLYCOSURIA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Renal and urinary disorders
MICROALBUMINURIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Renal and urinary disorders
DIABETIC NEPHROPATHY
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
General disorders
CHEST PAIN
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
General disorders
FATIGUE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
General disorders
MALAISE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
General disorders
OEDEMA PERIPHERAL
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
General disorders
PAIN
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
General disorders
PYREXIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
2.3%
2/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
BLOOD UREA INCREASED
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
1.1%
1/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
CRYSTAL URINE PRESENT
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
HEART RATE IRREGULAR
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
WEIGHT DECREASED
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
PROTEIN URINE PRESENT
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
URINE URIC ACID INCREASED
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
OPEN WOUND
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Surgical and medical procedures
ORCHIDECTOMY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
OBESITY
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/87 • 24 weeks
|
3.2%
3/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
CEREBRAL ATROPHY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
DIABETIC NEUROPATHY
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
DIZZINESS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
HEADACHE
|
1.1%
1/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
5.5%
5/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
MIGRAINE
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Nervous system disorders
SCIATICA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Nervous system disorders
CEREBROVASCULAR INSUFFICIENCY
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
CATARACT
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
CONJUNCTIVITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Eye disorders
DIABETIC RETINOPATHY
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
EYE INFLAMMATION
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
MACULAR DEGENERATION
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
AORTIC VALVE SCLEROSIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
CARDIOMYOPATHY
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
HYPERTENSIVE HEART DISEASE
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Cardiac disorders
MITRAL VALVE SCLEROSIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
FLUSHING
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
HYPERTENSION
|
5.7%
5/87 • 24 weeks
|
2.2%
2/93 • 24 weeks
|
3.3%
3/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Vascular disorders
VARICOSE ULCERATION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
MEASLES
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.9%
6/87 • 24 weeks
|
4.3%
4/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
8.0%
7/88 • 24 weeks
|
6.8%
6/88 • 24 weeks
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
PHARYNGITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Infections and infestations
PNEUMONIA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
RASH PUSTULAR
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
SINUSITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.3%
2/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
3.3%
3/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.3%
2/87 • 24 weeks
|
3.2%
3/93 • 24 weeks
|
2.2%
2/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Infections and infestations
VIRAL INFECTION
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
VULVAL ABSCESS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
GINGIVAL INFECTION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
GENITOURINARY TRACT INFECTION
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.3%
2/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Blood and lymphatic system disorders
HYPOCHROMIC ANAEMIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Blood and lymphatic system disorders
LYMPHATIC DISORDER
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
GOUT
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.3%
2/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
3.3%
3/91 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
BRONCHITIS
|
3.4%
3/87 • 24 weeks
|
3.2%
3/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
CYSTITIS
|
2.3%
2/87 • 24 weeks
|
4.3%
4/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
5.7%
5/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
1.1%
1/88 • 24 weeks
|
|
Infections and infestations
GASTROENTERITIS
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
1.1%
1/91 • 24 weeks
|
3.4%
3/88 • 24 weeks
|
2.3%
2/88 • 24 weeks
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
HERPES SIMPLEX
|
1.1%
1/87 • 24 weeks
|
0.00%
0/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
|
Infections and infestations
INFLUENZA
|
1.1%
1/87 • 24 weeks
|
1.1%
1/93 • 24 weeks
|
0.00%
0/91 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
0.00%
0/88 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER