Trial Outcomes & Findings for Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria (NCT NCT03449199)
NCT ID: NCT03449199
Last Updated: 2022-08-30
Results Overview
UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
TMX-049 Placebo
Placebo: Matching placebo to be taken orally, once daily
|
TMX-049 40mg QD
TMX-049: 40mg of TMX-049 to be taken orally, once daily
|
TMX-049 200mg QD
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
44
|
44
|
|
Overall Study
COMPLETED
|
41
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
TMX-049 Placebo
Placebo: Matching placebo to be taken orally, once daily
|
TMX-049 40mg QD
TMX-049: 40mg of TMX-049 to be taken orally, once daily
|
TMX-049 200mg QD
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
Baseline characteristics by cohort
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
66 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
68 years
STANDARD_DEVIATION 10 • n=206 Participants
|
66 years
STANDARD_DEVIATION 10.3 • n=157 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
76 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
105 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Weight
|
90.1 kg
STANDARD_DEVIATION 19.81 • n=99 Participants
|
95.9 kg
STANDARD_DEVIATION 20.58 • n=107 Participants
|
98.8 kg
STANDARD_DEVIATION 23.63 • n=206 Participants
|
95.0 kg
STANDARD_DEVIATION 21.57 • n=157 Participants
|
|
BMI
|
31.6 kg/m^2
STANDARD_DEVIATION 6.00 • n=99 Participants
|
33.6 kg/m^2
STANDARD_DEVIATION 6.57 • n=107 Participants
|
34.3 kg/m^2
STANDARD_DEVIATION 7.26 • n=206 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 6.69 • n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Modified Intention-to-Treat (mITT) Population consisted of all randomized subjects who had at least 1 post-randomization UACR assessment. Subjects in the mITT Population were analyzed according to their randomized treatment.
UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
|
-0.10 Log(mg/g)
Standard Error 0.153
|
-0.15 Log(mg/g)
Standard Error 0.151
|
-0.53 Log(mg/g)
Standard Error 0.150
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 6, 12, 16 (Follow-up)Population: Modified Intention-to-Treat (mITT) Population consisted of all randomized subjects who had at least 1 post-randomization UACR assessment. Subjects in the mITT Population were analyzed according to their randomized treatment.
Estimated Glomerular Filtration Rate from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured. The eGFR (estimated glomerular filtration rate) was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula based on the serum creatinine measurement.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Estimated Glomerular Filtration Rate (GFR)
Visit 4 (Week 2)
|
-0.02 ml/min/1.73 m^2
Standard Error 1.591
|
0.98 ml/min/1.73 m^2
Standard Error 1.601
|
0.18 ml/min/1.73 m^2
Standard Error 1.561
|
|
Changes in Estimated Glomerular Filtration Rate (GFR)
Visit 5 (Week 6)
|
-1.41 ml/min/1.73 m^2
Standard Error 1.757
|
-1.06 ml/min/1.73 m^2
Standard Error 1.732
|
0.00 ml/min/1.73 m^2
Standard Error 1.724
|
|
Changes in Estimated Glomerular Filtration Rate (GFR)
Visit 6/ET (Week 12)
|
-2.34 ml/min/1.73 m^2
Standard Error 1.585
|
-0.62 ml/min/1.73 m^2
Standard Error 1.563
|
1.09 ml/min/1.73 m^2
Standard Error 1.556
|
|
Changes in Estimated Glomerular Filtration Rate (GFR)
Visit 7/Follow up (Week 16)
|
-2.39 ml/min/1.73 m^2
Standard Error 1.726
|
1.57 ml/min/1.73 m^2
Standard Error 1.702
|
0.99 ml/min/1.73 m^2
Standard Error 1.695
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 6, 12, 16 (Follow-up)Population: Modified Intention-to-Treat (mITT) Population consisted of all randomized subjects who had at least 1 post-randomization UACR assessment. Subjects in the mITT Population were analyzed according to their randomized treatment
Serum Uric Acid from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured in order to explore the sUA (Serum Uric Acid) lowering effect in DKD (diabetic kidney disease) patients and the relationship between sUA and efficacy to DKD.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Serum Uric Acid (sUA)
Visit 4 (Week 2)
|
-0.03 mg/dL
Standard Error 0.238
|
-2.57 mg/dL
Standard Error 0.240
|
-3.54 mg/dL
Standard Error 0.234
|
|
Changes in Serum Uric Acid (sUA)
Visit 5 (Week 6)
|
-0.22 mg/dL
Standard Error 0.256
|
-2.54 mg/dL
Standard Error 0.252
|
-3.34 mg/dL
Standard Error 0.251
|
|
Changes in Serum Uric Acid (sUA)
Visit 6/ET (Week 12)
|
-0.07 mg/dL
Standard Error 0.269
|
-2.51 mg/dL
Standard Error 0.266
|
-3.30 mg/dL
Standard Error 0.265
|
|
Changes in Serum Uric Acid (sUA)
Visit 7/Follow up (Week 16)
|
0.21 mg/dL
Standard Error 0.190
|
-0.13 mg/dL
Standard Error 0.188
|
-0.33 mg/dL
Standard Error 0.187
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 6, 12, 16 (Follow-up)Population: Modified Intention-to-Treat (mITT) Population consisted of all randomized subjects who had at least 1 post-randomization UACR assessment. Subjects in the mITT Population were analyzed according to their randomized treatment
Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Visit 4 (Week 2)
|
25.44 mg/g
Standard Error 69.166
|
53.88 mg/g
Standard Error 68.229
|
-86.20 mg/g
Standard Error 67.932
|
|
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Visit 5 (Week 6)
|
-81.90 mg/g
Standard Error 68.156
|
-30.37 mg/g
Standard Error 67.233
|
-86.12 mg/g
Standard Error 66.940
|
|
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Visit 7/ Follow up (Week 16)
|
72.07 mg/g
Standard Error 90.045
|
58.31 mg/g
Standard Error 88.825
|
-8.27 mg/g
Standard Error 88.439
|
|
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Visit 6/ET (Week 12)
|
61.92 mg/g
Standard Error 92.291
|
-40.10 mg/g
Standard Error 91.041
|
-135.57 mg/g
Standard Error 90.645
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Modified Intention-to-Treat (mITT) Population consisted of all randomized subjects who had at least 1 post-randomization UACR assessment. Subjects in the mITT Population were analyzed according to their randomized treatment.
Changes in Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio were measured. Subject with greater than 30% reduction is estimated as responder, less than or equal to 30% reduction is estimated as non-responder.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=43 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
Responder
|
10 Participants
|
14 Participants
|
19 Participants
|
|
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
Non-responder
|
32 Participants
|
29 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Blood Biomarkers for inflammation (C Reactive Protein) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Visit 4 (Week 2)
|
0.046 mg/dL
Standard Deviation 0.5168
|
0.014 mg/dL
Standard Deviation 0.5384
|
0.087 mg/dL
Standard Deviation 0.6194
|
|
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Visit 5 (Week 6)
|
-0.011 mg/dL
Standard Deviation 0.6443
|
0.003 mg/dL
Standard Deviation 0.3688
|
-0.084 mg/dL
Standard Deviation 0.4303
|
|
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Visit 6/ET (Week 12)
|
0.000 mg/dL
Standard Deviation 0.7527
|
-0.144 mg/dL
Standard Deviation 0.3691
|
0.000 mg/dL
Standard Deviation 0.5176
|
|
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Visit 7/ Follow up (Week 16)
|
0.012 mg/dL
Standard Deviation 0.6507
|
-0.084 mg/dL
Standard Deviation 0.3606
|
-0.046 mg/dL
Standard Deviation 0.3917
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Blood Biomarkers for inflammation (Soluble TNF \[tumor necrosis factor\] Receptor Type I) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Visit 4 (Week 2)
|
-13.7 ng/L
Standard Deviation 367.11
|
-92.3 ng/L
Standard Deviation 298.83
|
38.7 ng/L
Standard Deviation 360.03
|
|
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Visit 5 (Week 6)
|
-77.1 ng/L
Standard Deviation 295.50
|
47.6 ng/L
Standard Deviation 485.92
|
60.7 ng/L
Standard Deviation 397.76
|
|
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Visit 6 (Week 12)
|
16.5 ng/L
Standard Deviation 371.88
|
10.8 ng/L
Standard Deviation 455.11
|
43.8 ng/L
Standard Deviation 265.35
|
|
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Visit 7/Follow up (Week 16)
|
-25.8 ng/L
Standard Deviation 366.94
|
-36.3 ng/L
Standard Deviation 308.79
|
13.8 ng/L
Standard Deviation 320.22
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Fatty Acid Binding Protein 1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Visit 4 (Week 2)
|
0.03 ug/L/mg/dL
Standard Deviation 0.161
|
0.01 ug/L/mg/dL
Standard Deviation 0.214
|
-0.04 ug/L/mg/dL
Standard Deviation 0.201
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Visit 5 (Week 6)
|
-0.04 ug/L/mg/dL
Standard Deviation 0.309
|
0.04 ug/L/mg/dL
Standard Deviation 0.258
|
-0.04 ug/L/mg/dL
Standard Deviation 0.201
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Visit 6 (Week 12)
|
-0.01 ug/L/mg/dL
Standard Deviation 0.317
|
-0.01 ug/L/mg/dL
Standard Deviation 0.136
|
-0.01 ug/L/mg/dL
Standard Deviation 0.218
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Visit 7/Follow up (Week 16)
|
0.02 ug/L/mg/dL
Standard Deviation 0.321
|
0.04 ug/L/mg/dL
Standard Deviation 0.289
|
0.00 ug/L/mg/dL
Standard Deviation 0.188
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Hydroxy Deoxyguanosine) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Visit 4 (Week 2)
|
1.47 nmol/L/mg/dL
Standard Deviation 4.266
|
4.70 nmol/L/mg/dL
Standard Deviation 4.123
|
6.08 nmol/L/mg/dL
Standard Deviation 5.809
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Visit 5 (Week 6)
|
1.72 nmol/L/mg/dL
Standard Deviation 5.179
|
3.22 nmol/L/mg/dL
Standard Deviation 5.321
|
4.88 nmol/L/mg/dL
Standard Deviation 5.930
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Visit 6 (Week 12)
|
-1.86 nmol/L/mg/dL
Standard Deviation 5.372
|
3.75 nmol/L/mg/dL
Standard Deviation 6.157
|
6.87 nmol/L/mg/dL
Standard Deviation 10.476
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Visit 7/ Follow up (Week 16)
|
1.20 nmol/L/mg/dL
Standard Deviation 5.480
|
-0.07 nmol/L/mg/dL
Standard Deviation 5.647
|
-3.14 nmol/L/mg/dL
Standard Deviation 5.211
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Kidney Injury Molecule-1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Visit 4 (Week 2)
|
0.00 ug/L/mg/dL
Standard Deviation 0.010
|
0.00 ug/L/mg/dL
Standard Deviation 0.016
|
0.00 ug/L/mg/dL
Standard Deviation 0.007
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Visit 5 (Week 6)
|
0.00 ug/L/mg/dL
Standard Deviation 0.010
|
0.00 ug/L/mg/dL
Standard Deviation 0.015
|
0.00 ug/L/mg/dL
Standard Deviation 0.006
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Visit 6 (Week 12)
|
0.00 ug/L/mg/dL
Standard Deviation 0.019
|
0.00 ug/L/mg/dL
Standard Deviation 0.015
|
0.00 ug/L/mg/dL
Standard Deviation 0.008
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Visit 7/Follow up (Week 16)
|
0.00 ug/L/mg/dL
Standard Deviation 0.009
|
0.00 ug/L/mg/dL
Standard Deviation 0.0014
|
0.00 ug/L/mg/dL
Standard Deviation 0.009
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Safety Population consisted of all randomized subjects who received at least one study drug tablet or capsule. Subjects were analyzed according to the actual treatment received.
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Outcome measures
| Measure |
TMX-049 Placebo
n=42 Participants
Placebo: Matching placebo to be taken orally, once daily, for 12 weeks
|
TMX-049 40 mg QD
n=44 Participants
TMX-049: 40 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
TMX-049 200 mg QD
n=44 Participants
TMX-049: 200 mg of TMX-049 to be taken orally, once daily for 12 weeks
|
|---|---|---|---|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Visit 4 (Week 2)
|
-0.01 U/L/mg/dL
Standard Deviation 0.129
|
0.03 U/L/mg/dL
Standard Deviation 0.136
|
-0.01 U/L/mg/dL
Standard Deviation 0.152
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Visit 5 (Week 6)
|
0.02 U/L/mg/dL
Standard Deviation 0.154
|
0.02 U/L/mg/dL
Standard Deviation 0.121
|
-0.02 U/L/mg/dL
Standard Deviation 0.147
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Visit 6 (Week 12)
|
0.00 U/L/mg/dL
Standard Deviation 0.123
|
0.02 U/L/mg/dL
Standard Deviation 0.143
|
-0.02 U/L/mg/dL
Standard Deviation 0.108
|
|
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Visit 7/Follow up (Week 16)
|
0.01 U/L/mg/dL
Standard Deviation 0.089
|
0.02 U/L/mg/dL
Standard Deviation 0.116
|
-0.01 U/L/mg/dL
Standard Deviation 0.132
|
Adverse Events
TMX-049 Placebo
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
TMX-049 40 mg QD
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
TMX-049: 200 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMX-049 Placebo
n=42 participants at risk
Placebo: Matching placebo to be taken orally, once daily
|
TMX-049 40 mg QD
n=44 participants at risk
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
|
TMX-049: 200 mg
n=44 participants at risk
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Cholecystitis infective
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
Other adverse events
| Measure |
TMX-049 Placebo
n=42 participants at risk
Placebo: Matching placebo to be taken orally, once daily
|
TMX-049 40 mg QD
n=44 participants at risk
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
|
TMX-049: 200 mg
n=44 participants at risk
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Ear and labyrinth disorders
Middle ear disorder
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
2/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
6.8%
3/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
6.8%
3/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
6.8%
3/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
General disorders
Chest pain
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
General disorders
Drug interaction
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
General disorders
Oedema
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
General disorders
Oedema peripheral
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
6.8%
3/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Viral infection
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Blood glucose increased
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Haematology test abnormal
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Investigations
Weight increased
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
4.5%
2/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Headache
|
4.8%
2/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Renal and urinary disorders
Renal impairment
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Vascular disorders
Peripheral artery aneurysm
|
2.4%
1/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/42 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
2.3%
1/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
0.00%
0/44 • Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.
Treatment-emergent AEs (TEAEs) were defined as any events with start date on or after the date of first dose of double-blind study drug and up to 30 days after date of last dose of double-blind study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place