Trial Outcomes & Findings for A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study (NCT NCT00432679)
NCT ID: NCT00432679
Last Updated: 2022-12-12
Results Overview
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
Baseline (Day 0) and Week 16
Results posted on
2022-12-12
Participant Flow
From 19 April 2006 to 28 March 2007, total of 149 participants were randomized at 22 centers in Japan.
Out of 172 participants given consent to participate in the study, 23 participants were withdrawn from the study before randomization.
Participant milestones
| Measure |
Rosiglitazone 4 mg Orally Once Daily
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 milligrams (mg) tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
69
|
72
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Rosiglitazone 4 mg Orally Once Daily
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 milligrams (mg) tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Baseline characteristics by cohort
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
61.6 Years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
|
-0.62 Percentage of Glycosylated Hemoglobin
Standard Deviation 0.074
|
0.19 Percentage of Glycosylated Hemoglobin
Standard Deviation 0.073
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
|
-15.9 Mg per decilliter
Standard Deviation 28.91
|
6.2 Mg per decilliter
Standard Deviation 32.69
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=73 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
|
-0.479 Microunits per millilliter
Standard Deviation 3.2699
|
-1.197 Microunits per millilliter
Standard Deviation 6.1434
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=73 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
|
-1.64 Picomoles per millilliter
Standard Deviation 13.630
|
0.40 Picomoles per millilliter
Standard Deviation 11.666
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=73 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
-0.496 MilliUnit per liter*millimoles per liter
Standard Deviation 1.5562
|
-0.486 MilliUnit per liter*millimoles per liter
Standard Deviation 3.7556
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=73 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
|
3.776 Percentage of normal beta cells function
Standard Deviation 18.7875
|
-4.444 Percentage of normal beta cells function
Standard Deviation 24.0408
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Adiponectin
|
9.19 Micrograms per millilliter
Standard Deviation 7.030
|
0.98 Micrograms per millilliter
Standard Deviation 2.301
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 16Population: Full analysis set used. Only those participants available at the specified time points were analyzed.
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Hs-CRP
|
-189.1 Nanograms per millilliter
Standard Deviation 5376.91
|
699.7 Nanograms per millilliter
Standard Deviation 4349.58
|
|
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Leptin
|
0.59 Nanograms per millilliter
Standard Deviation 2.751
|
-0.07 Nanograms per millilliter
Standard Deviation 1.332
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Full analysis set used.
The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.
Outcome measures
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 Participants
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 Participants
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
HbA1c, decrease by 0.7%
|
44.6 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
HbA1c, fell below 6.5%
|
6.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
HbA1c, satisfied either 1 or 2
|
44.6 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
FPG, decrease of 30 milligrams per decilliter
|
31.1 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
FPG, fell below 126 milligrams per deciliter
|
16.2 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
FPG, satisfied either 1 or 2
|
35.1 Percentage of participants
|
14.7 Percentage of participants
|
Adverse Events
Rosiglitazone 4 mg Orally Once Daily
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 participants at risk
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 participants at risk
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposacromal recurrent
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
Other adverse events
| Measure |
Rosiglitazone 4 mg Orally Once Daily
n=74 participants at risk
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
Placebo
n=75 participants at risk
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study.
|
|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
12.2%
9/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
4.0%
3/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Weight increased
|
13.5%
10/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood triglyccrides increased
|
9.5%
7/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood pressure increased
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
5.3%
4/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Brain natriuretic peptide increased
|
4.1%
3/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood cholesterol increased
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Urine ketone body present
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
4.0%
3/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood urine present
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Hjgh density lipoprotein decreased
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Low density lipoprotein increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Protein urine present
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood albumin decreased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Liver function test abnormal
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Monocyte count increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Neutrophll count decreased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Reticulocyte count increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Weight decreased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
White blood cell count decreased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
White blood cell count increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
10/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
16.0%
12/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Pharyngitis
|
4.1%
3/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
4.0%
3/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Cystitis
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Hordeolum
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Impetigo
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
lnfluenza
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Infections and infestations
Skin infection
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
3/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Gastritis
|
4.1%
3/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Reflux ocsophagitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Periodontitis
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Duodenal scarring
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.8%
8/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
14.7%
11/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal discomfort
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Myajgia
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Oedema peripheral
|
8.1%
6/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Pyrexia
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Chest discomfort
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Chest pain
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Feeling abnonnal
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Malaise
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Oedema
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Pain
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
General disorders
Thirst
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
4.0%
3/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Thennal bum
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Headache
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Dizziness
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Hypoaesthcsia
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Areflexia
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Sciatica
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Nervous system disorders
Tension headache
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
3/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
2/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Conjunctivitis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
2.7%
2/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Cataract
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Corneal epithelium disorder
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Diabetic retinopathy
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Lacrimation increased
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Eye disorders
Corneal exfoliation
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Psychiatric disorders
Anxiety disorder
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Cardiac disorders
Bundle branch block right
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Renal and urinary disorders
Pollakiuria
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Endocrine disorders
Adrenal mass
|
1.4%
1/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
0.00%
0/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/74 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
1.3%
1/75 • All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER