Trial Outcomes & Findings for Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure (NCT NCT01258387)
NCT ID: NCT01258387
Last Updated: 2014-07-01
Results Overview
Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2014-07-01
Participant Flow
After informed consent, 40 patients with symptomatic Heart Failure (HF) were randomized (4:2) to GGF2 or placebo in 7 ascending dose cohorts. Patients were observed in hospital for 30 hours, then evaluated for adverse effects at 1, 2, 4, 12, and 24 weeks after infusion.
There were six patients in each cohort/dose level, four received active treatment (GGF2) and two received placebo. In each dose level, the first two patients were randomized 1:1 to GGF2 or placebo and monitored for safety prior to randomizing the remaining patients in the cohort 3:1. GGF2 or placebo was administered as an IV infusion.
Participant milestones
| Measure |
GGF2 First Dose
First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
GGF2 Second Escalated Dose
Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
GGF2 Third Escalated Dose
Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
GGF2 Fourth Escalated Dose
Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
GGF2 Fifth Escalated Dose
Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
GGF2 Sixth Escalated Dose
Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
|
GGF2 Seventh Escalataed Dose
Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
|
Overall Study
Patients Randomized to GGF2
|
4
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Overall Study
Patients Randomized to Placebo
|
2
|
2
|
2
|
2
|
2
|
2
|
1
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Patients in each of 7 cohorts randomized to Placebo
|
GGF2 First Dose
n=4 Participants
First dosing: patients in cohort randomized to GGF2
|
GGF2 Second Escalated Dose
n=4 Participants
Second dosing: patients in cohort randomized to GGF2
|
GGF2 Third Escalated Dose
n=4 Participants
Third dosing: patients in cohort randomized to GGF2
|
GGF2 Fourth Escalated Dose
n=4 Participants
Fourth dosing: patients in cohort randomized to GGF2
|
GGF2 Fifth Escalated Dose
n=4 Participants
Fifth dosing: patients in cohort randomized to GGF2
|
GGF2 Sixth Escalated Dose
n=4 Participants
Sixth dosing: patients in cohort randomized to GGF2.
|
GGF2 Seventh Escalataed Dose
n=3 Participants
Seventh dosing: patients in cohort randomized to GGF2
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 13.21 • n=99 Participants
|
52.0 years
STANDARD_DEVIATION 5.72 • n=107 Participants
|
58.5 years
STANDARD_DEVIATION 7.59 • n=206 Participants
|
56.8 years
STANDARD_DEVIATION 10.05 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 5.85 • n=31 Participants
|
58.5 years
STANDARD_DEVIATION 8.85 • n=30 Participants
|
59.0 years
STANDARD_DEVIATION 4.97 • n=3 Participants
|
61.0 years
STANDARD_DEVIATION 9.17 • n=6 Participants
|
57.4 years
STANDARD_DEVIATION 9.83 • n=114 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
33 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
40 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety population
Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.
Outcome measures
| Measure |
Placebo
n=13 Participants
|
GGF2 First Dose
n=4 Participants
|
GGF2 Second Escalated Dose
n=4 Participants
|
GGF2 Third Escalated Dose
n=4 Participants
|
GGF2 Fourth Escalated Dose
n=4 Participants
|
GGF2 Fifth Escalated Dose
n=4 Participants
|
GGF2 Sixth Escalated Dose
n=4 Participants
|
GGF2 Seventh Escalataed Dose
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having Any TEAEs - Yes
|
6 participants
|
4 participants
|
4 participants
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
3 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having Any TEAEs - No
|
7 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Severity Mild
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Severity Moderate
|
1 participants
|
3 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Severity Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Toxicity Grade Mild
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Toxicity Grade Moderate
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Toxicity Grade Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
TEAEs Maximum Toxicity Grade Life-Threatening
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Having TEAEs Maximum Toxicity Grade Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Relationship to Study Drug -Not Related
|
5 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Relationship to Study Drug -Related
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Withdrew Due to TEAEs - Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Withdrew Due to TEAEs - NO
|
13 participants
|
4 participants
|
4 participants
|
4 participants
|
4 participants
|
4 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Screening, day 8, day 14, day 28, and 3 months post-dosePopulation: Safety Population
An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286
Outcome measures
| Measure |
Placebo
n=13 Participants
|
GGF2 First Dose
n=4 Participants
|
GGF2 Second Escalated Dose
n=4 Participants
|
GGF2 Third Escalated Dose
n=4 Participants
|
GGF2 Fourth Escalated Dose
n=4 Participants
|
GGF2 Fifth Escalated Dose
n=4 Participants
|
GGF2 Sixth Escalated Dose
n=4 Participants
|
GGF2 Seventh Escalataed Dose
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
Day 8
|
-0.82 percent change
Standard Deviation 6.582
|
4.75 percent change
Standard Deviation 8.180
|
5.00 percent change
Standard Deviation 7.528
|
2.50 percent change
Standard Deviation 5.196
|
4.25 percent change
Standard Deviation 4.272
|
-1.25 percent change
Standard Deviation 4.992
|
5.33 percent change
Standard Deviation 8.083
|
4.33 percent change
Standard Deviation 3.055
|
|
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
Day 14
|
-1.12 percent change
Standard Deviation 7.880
|
-5.00 percent change
Standard Deviation 7.257
|
5.00 percent change
Standard Deviation 10.863
|
2.00 percent change
Standard Deviation 4.546
|
4.23 percent change
Standard Deviation 8.328
|
2.13 percent change
Standard Deviation 5.360
|
11.55 percent change
Standard Deviation 10.007
|
7.10 percent change
Standard Deviation 8.627
|
|
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
Day 28
|
-0.27 percent change
Standard Deviation 8.584
|
-2.00 percent change
Standard Deviation 9.345
|
8.50 percent change
Standard Deviation 10.472
|
4.00 percent change
Standard Deviation 2.449
|
8.00 percent change
Standard Deviation 2.000
|
5.75 percent change
Standard Deviation 2.500
|
12.00 percent change
Standard Deviation 5.099
|
10.00 percent change
Standard Deviation 7.550
|
|
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
3 Months
|
1.88 percent change
Standard Deviation 8.588
|
-3.75 percent change
Standard Deviation 6.397
|
0.78 percent change
Standard Deviation 8.418
|
0.75 percent change
Standard Deviation 4.031
|
7.25 percent change
Standard Deviation 8.770
|
4.50 percent change
Standard Deviation 7.724
|
9.00 percent change
Standard Deviation 5.598
|
15.00 percent change
Standard Deviation 13.000
|
SECONDARY outcome
Timeframe: Screening, day 8, day 14, day 28, and 3 months post-dosePopulation: Safety Population
EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Outcome measures
| Measure |
Placebo
n=13 Participants
|
GGF2 First Dose
n=4 Participants
|
GGF2 Second Escalated Dose
n=4 Participants
|
GGF2 Third Escalated Dose
n=4 Participants
|
GGF2 Fourth Escalated Dose
n=4 Participants
|
GGF2 Fifth Escalated Dose
n=4 Participants
|
GGF2 Sixth Escalated Dose
n=4 Participants
|
GGF2 Seventh Escalataed Dose
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
Day 8
|
-14.89 Milliliter(s)
Standard Deviation 74.125
|
27.50 Milliliter(s)
Standard Deviation 27.538
|
1.98 Milliliter(s)
Standard Deviation 29.028
|
-10.60 Milliliter(s)
Standard Deviation 59.288
|
-2.15 Milliliter(s)
Standard Deviation 11.098
|
-35.00 Milliliter(s)
Standard Deviation 36.341
|
17.00 Milliliter(s)
Standard Deviation 23.763
|
7.33 Milliliter(s)
Standard Deviation 5.859
|
|
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
Day 14
|
-41.59 Milliliter(s)
Standard Deviation 55.252
|
31.95 Milliliter(s)
Standard Deviation 9.450
|
-10.25 Milliliter(s)
Standard Deviation 56.119
|
-32.83 Milliliter(s)
Standard Deviation 44.543
|
-22.25 Milliliter(s)
Standard Deviation 30.609
|
-26.50 Milliliter(s)
Standard Deviation 33.071
|
-23.50 Milliliter(s)
Standard Deviation 61.474
|
17.85 Milliliter(s)
Standard Deviation 19.587
|
|
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
Day 28
|
-25.85 Milliliter(s)
Standard Deviation 63.405
|
13.60 Milliliter(s)
Standard Deviation 21.750
|
49.18 Milliliter(s)
Standard Deviation 52.333
|
-21.05 Milliliter(s)
Standard Deviation 41.282
|
10.50 Milliliter(s)
Standard Deviation 54.482
|
-15.80 Milliliter(s)
Standard Deviation 20.785
|
-15.25 Milliliter(s)
Standard Deviation 74.384
|
-3.30 Milliliter(s)
Standard Deviation 13.262
|
|
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
3 Months
|
-25.72 Milliliter(s)
Standard Deviation 109.056
|
2.85 Milliliter(s)
Standard Deviation 43.507
|
-8.00 Milliliter(s)
Standard Deviation 46.168
|
48.78 Milliliter(s)
Standard Deviation 66.896
|
-20.00 Milliliter(s)
Standard Deviation 36.615
|
-39.85 Milliliter(s)
Standard Deviation 52.616
|
-12.98 Milliliter(s)
Standard Deviation 116.297
|
4.07 Milliliter(s)
Standard Deviation 30.624
|
SECONDARY outcome
Timeframe: Screening, day 8, day 14, day 28, and 3 months post-dosePopulation: Safety Population
ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Outcome measures
| Measure |
Placebo
n=13 Participants
|
GGF2 First Dose
n=4 Participants
|
GGF2 Second Escalated Dose
n=4 Participants
|
GGF2 Third Escalated Dose
n=4 Participants
|
GGF2 Fourth Escalated Dose
n=4 Participants
|
GGF2 Fifth Escalated Dose
n=4 Participants
|
GGF2 Sixth Escalated Dose
n=4 Participants
|
GGF2 Seventh Escalataed Dose
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
3 Months
|
-12.65 Milliliter(s)
Standard Deviation 128.433
|
6.30 Milliliter(s)
Standard Deviation 32.395
|
-0.45 Milliliter(s)
Standard Deviation 32.211
|
27.80 Milliliter(s)
Standard Deviation 43.414
|
-21.25 Milliliter(s)
Standard Deviation 23.782
|
-39.08 Milliliter(s)
Standard Deviation 48.393
|
-18.58 Milliliter(s)
Standard Deviation 87.663
|
-10.73 Milliliter(s)
Standard Deviation 36.960
|
|
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
Day 8
|
-0.92 Milliliter(s)
Standard Deviation 79.285
|
12.38 Milliliter(s)
Standard Deviation 31.669
|
-6.98 Milliliter(s)
Standard Deviation 29.443
|
-15.95 Milliliter(s)
Standard Deviation 44.215
|
-5.25 Milliliter(s)
Standard Deviation 15.392
|
-26.50 Milliliter(s)
Standard Deviation 30.490
|
-9.00 Milliliter(s)
Standard Deviation 29.017
|
-3.23 Milliliter(s)
Standard Deviation 12.894
|
|
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
Day 14
|
-19.08 Milliliter(s)
Standard Deviation 76.181
|
33.20 Milliliter(s)
Standard Deviation 14.200
|
-14.40 Milliliter(s)
Standard Deviation 30.961
|
-27.65 Milliliter(s)
Standard Deviation 31.115
|
-15.00 Milliliter(s)
Standard Deviation 20.314
|
-27.25 Milliliter(s)
Standard Deviation 39.339
|
-31.75 Milliliter(s)
Standard Deviation 58.750
|
4.10 Milliliter(s)
Standard Deviation 2.970
|
|
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
Day 28
|
-3.48 Milliliter(s)
Standard Deviation 92.552
|
10.88 Milliliter(s)
Standard Deviation 22.885
|
22.05 Milliliter(s)
Standard Deviation 41.977
|
-23.45 Milliliter(s)
Standard Deviation 30.330
|
-8.88 Milliliter(s)
Standard Deviation 25.873
|
-24.75 Milliliter(s)
Standard Deviation 26.725
|
-28.75 Milliliter(s)
Standard Deviation 60.808
|
-16.30 Milliliter(s)
Standard Deviation 8.311
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GGF2 First Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GGF2 Second Escalated Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GGF2 Third Escalated Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GGF2 Fourth Escalated Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GGF2 Fifth Escalated Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GGF2 Sixth Escalated Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GGF2 Seventh Escalataed Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
|
GGF2 First Dose
n=4 participants at risk
First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Second Escalated Dose
n=4 participants at risk
Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Third Escalated Dose
n=4 participants at risk
Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Fourth Escalated Dose
n=4 participants at risk
Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Fifth Escalated Dose
n=4 participants at risk
Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Sixth Escalated Dose
n=4 participants at risk
Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
|
GGF2 Seventh Escalataed Dose
n=3 participants at risk
Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • Number of events 1 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • Number of events 1 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Hepatobiliary disorders
Hy's law case
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • Number of events 1 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • Number of events 1 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
|
GGF2 First Dose
n=4 participants at risk
First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Second Escalated Dose
n=4 participants at risk
Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Third Escalated Dose
n=4 participants at risk
Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Fourth Escalated Dose
n=4 participants at risk
Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Fifth Escalated Dose
n=4 participants at risk
Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
GGF2 Sixth Escalated Dose
n=4 participants at risk
Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
|
GGF2 Seventh Escalataed Dose
n=3 participants at risk
Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
66.7%
2/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
66.7%
2/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
66.7%
2/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Fatigue
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Injection site haematoma
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Injection site scab
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
100.0%
3/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Blood chloride increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal conjestion
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
50.0%
2/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Vascular disorders
Vein pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
25.0%
1/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
|
Hepatobiliary disorders
Hy's law case
|
0.00%
0/13 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
0.00%
0/4 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
33.3%
1/3 • 6 months
Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (Acorda) has the right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
- Publication restrictions are in place
Restriction type: OTHER