Trial Outcomes & Findings for Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control (NCT NCT01066039)
NCT ID: NCT01066039
Last Updated: 2014-07-04
Results Overview
HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
202 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2014-07-04
Participant Flow
Participant milestones
| Measure |
Bisoprolol
Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Overall Study
STARTED
|
202
|
|
Overall Study
Treated
|
200
|
|
Overall Study
COMPLETED
|
158
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Bisoprolol
Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Inclusion/Exclusion Criteria Violation
|
9
|
|
Overall Study
Investigator's Request
|
1
|
|
Overall Study
Dropout due to Insulin Administration
|
1
|
|
Overall Study
Additional Antihypertensive Required
|
4
|
|
Overall Study
Volunteer Failed to Make the Next Visit
|
2
|
|
Overall Study
Failure to Control Blood Pressure
|
1
|
|
Overall Study
Drug/Dose Adjustment Required
|
1
|
Baseline Characteristics
Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control
Baseline characteristics by cohort
| Measure |
Bisoprolol
n=202 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.
HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6
Baseline
|
6.79 Percent HbA1c
Standard Deviation 0.66
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6
Change at Month 6
|
0.26 Percent HbA1c
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.
HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline.
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3
|
0.15 Percent HbA1c
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.
The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus \[{SBP minus DBP} divided by 3\]).
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
SBP: Baseline
|
147.8 mmHg
Standard Deviation 11.5
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
SBP: Change at Month 6
|
-13.4 mmHg
Standard Deviation 15.4
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
DBP: Baseline
|
89.0 mmHg
Standard Deviation 7.3
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
DBP: Change at Month 6
|
-9.1 mmHg
Standard Deviation 9.0
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
Mean BP: Baseline
|
108.6 mmHg
Standard Deviation 6.9
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6
Mean BP: Change at Month 6
|
-10.5 mmHg
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.
HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI \[micro international units per milliliter {mcIU/mL}\] \* FPG \[millimole per liter {mmol/L}\]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline.
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6
Baseline
|
2.3 mcIU/mL * mmol/L
Standard Deviation 1.8
|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6
Change at Month 3
|
0.1 mcIU/mL * mmol/L
Standard Deviation 1.8
|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6
Change at Month 6
|
0.4 mcIU/mL * mmol/L
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.
The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline.
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Insulin Level at Months 3 and 6
Change at Month 3
|
0.2 mcIU/mL
Standard Deviation 4.5
|
|
Change From Baseline in Insulin Level at Months 3 and 6
Change at Month 6
|
0.6 mcIU/mL
Standard Deviation 6.0
|
|
Change From Baseline in Insulin Level at Months 3 and 6
Baseline
|
7.5 mcIU/mL
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.
The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline.
Outcome measures
| Measure |
Bisoprolol
n=175 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in C-Peptide Level at Months 3 and 6
Baseline
|
2.3 nanogram per milliliter (ng/mL)
Standard Deviation 0.9
|
|
Change From Baseline in C-Peptide Level at Months 3 and 6
Change at Month 3
|
0.1 nanogram per milliliter (ng/mL)
Standard Deviation 0.8
|
|
Change From Baseline in C-Peptide Level at Months 3 and 6
Change at Month 6
|
0.2 nanogram per milliliter (ng/mL)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.
The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively.
Outcome measures
| Measure |
Bisoprolol
n=174 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
Total Cholesterol: Baseline (n = 174)
|
168.6 milligram per deciliter (mg/dL)
Standard Deviation 32.3
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
Total Cholesterol: Change at Month 6 (n = 173)
|
-0.8 milligram per deciliter (mg/dL)
Standard Deviation 26.3
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
LDL: Baseline (n = 174)
|
93.3 milligram per deciliter (mg/dL)
Standard Deviation 26.3
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
LDL: Change at Month 6 (n = 173)
|
-1.6 milligram per deciliter (mg/dL)
Standard Deviation 22.5
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
HDL: Baseline (n = 174)
|
49.2 milligram per deciliter (mg/dL)
Standard Deviation 11.7
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
HDL: Change at Month 6 (n = 173)
|
-3.4 milligram per deciliter (mg/dL)
Standard Deviation 8.0
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
Triglyceride: Baseline (n = 174)
|
155.0 milligram per deciliter (mg/dL)
Standard Deviation 96.3
|
|
Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6
Triglyceride: Change at Month 6 (n = 173)
|
13.5 milligram per deciliter (mg/dL)
Standard Deviation 87.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.
The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline.
Outcome measures
| Measure |
Bisoprolol
n=89 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Albumin/Creatinine Ratio at Month 6
Baseline (n = 89)
|
127.7 ratio
Standard Deviation 630.9
|
|
Change From Baseline in Albumin/Creatinine Ratio at Month 6
Change at Month 6 (n = 85)
|
34.3 ratio
Standard Deviation 186.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.
The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline.
Outcome measures
| Measure |
Bisoprolol
n=167 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Change From Baseline in Microalbumin Level at Month 6
Baseline (n = 167)
|
56.6 mg/dL
Standard Deviation 261.6
|
|
Change From Baseline in Microalbumin Level at Month 6
Change at Month 6 (n = 161)
|
-3.1 mg/dL
Standard Deviation 204.4
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: Safety population included all participants who received at least one dose of investigational product.
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Outcome measures
| Measure |
Bisoprolol
n=200 Participants
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
68 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
7 participants
|
Adverse Events
Bisoprolol
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bisoprolol
n=200 participants at risk
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture lower limb
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Fracture rib
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Fracture upper limb
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.50%
1/200 • Baseline up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Baseline up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder carcinoma
|
0.50%
1/200 • Baseline up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.50%
1/200 • Baseline up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm metastatic
|
0.50%
1/200 • Baseline up to Month 6
|
Other adverse events
| Measure |
Bisoprolol
n=200 participants at risk
Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
|
|---|---|
|
General disorders
Oedema
|
0.50%
1/200 • Baseline up to Month 6
|
|
General disorders
Oedema periorbital
|
0.50%
1/200 • Baseline up to Month 6
|
|
General disorders
Pain legs
|
0.50%
1/200 • Baseline up to Month 6
|
|
General disorders
Sensation of warmth
|
0.50%
1/200 • Baseline up to Month 6
|
|
General disorders
Weakness generalized
|
1.5%
3/200 • Baseline up to Month 6
|
|
Cardiac disorders
ECG abnormal
|
0.50%
1/200 • Baseline up to Month 6
|
|
Cardiac disorders
AV block first degree
|
0.50%
1/200 • Baseline up to Month 6
|
|
Cardiac disorders
Bradyarrhythmia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Cardiac disorders
Palpitation
|
0.50%
1/200 • Baseline up to Month 6
|
|
Nervous system disorders
Dizziness
|
3.0%
6/200 • Baseline up to Month 6
|
|
Nervous system disorders
Dizziness postural
|
0.50%
1/200 • Baseline up to Month 6
|
|
Nervous system disorders
Headache
|
4.0%
8/200 • Baseline up to Month 6
|
|
Nervous system disorders
Numbness
|
1.0%
2/200 • Baseline up to Month 6
|
|
Nervous system disorders
Vocal cord paralysis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
2/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Colonic polyp
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
3/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
2/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Enteritis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gastritis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gastritis aggravated
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gastro-intestinal disorder nos
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Gingivitis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Nausea
|
1.0%
2/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Periodontitis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.0%
2/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Tooth ache
|
0.50%
1/200 • Baseline up to Month 6
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/200 • Baseline up to Month 6
|
|
Hepatobiliary disorders
Biliary stones
|
0.50%
1/200 • Baseline up to Month 6
|
|
Hepatobiliary disorders
Liver fatty
|
0.50%
1/200 • Baseline up to Month 6
|
|
Hepatobiliary disorders
Liver function tests abnormal nos
|
0.50%
1/200 • Baseline up to Month 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Metabolism and nutrition disorders
Hyperlipaemia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.0%
2/200 • Baseline up to Month 6
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Metabolism and nutrition disorders
Weight decrease
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.50%
1/200 • Baseline up to Month 6
|
|
Musculoskeletal and connective tissue disorders
Pain neck/shoulder
|
0.50%
1/200 • Baseline up to Month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Larynx neoplasm benign
|
0.50%
1/200 • Baseline up to Month 6
|
|
Psychiatric disorders
Insomnia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Investigations
Anaemia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Infections and infestations
Common cold
|
1.5%
3/200 • Baseline up to Month 6
|
|
Infections and infestations
Coryza
|
0.50%
1/200 • Baseline up to Month 6
|
|
Infections and infestations
Rhinitis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Infections and infestations
Tinea pedis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
2/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
2.0%
4/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.50%
1/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.50%
1/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Sputum disorder
|
0.50%
1/200 • Baseline up to Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
1.0%
2/200 • Baseline up to Month 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.50%
1/200 • Baseline up to Month 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
2/200 • Baseline up to Month 6
|
|
Skin and subcutaneous tissue disorders
Pruritus aggravated
|
0.50%
1/200 • Baseline up to Month 6
|
|
Skin and subcutaneous tissue disorders
Skin injury
|
0.50%
1/200 • Baseline up to Month 6
|
|
Renal and urinary disorders
Albuminuria
|
0.50%
1/200 • Baseline up to Month 6
|
|
Renal and urinary disorders
Polyuria
|
0.50%
1/200 • Baseline up to Month 6
|
|
Renal and urinary disorders
Renal cyst
|
1.0%
2/200 • Baseline up to Month 6
|
|
Vascular disorders
Peripheral coldness
|
0.50%
1/200 • Baseline up to Month 6
|
|
Eye disorders
Allergic conjunctivitis aggravated
|
0.50%
1/200 • Baseline up to Month 6
|
|
Eye disorders
Cataract aggravated
|
0.50%
1/200 • Baseline up to Month 6
|
|
Eye disorders
Conjunctivitis
|
0.50%
1/200 • Baseline up to Month 6
|
|
Eye disorders
Eye abnormality
|
0.50%
1/200 • Baseline up to Month 6
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place