Trial Outcomes & Findings for Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (NCT NCT03281577)
NCT ID: NCT03281577
Last Updated: 2021-01-07
Results Overview
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
Results posted on
2021-01-07
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 02 January 2018 to 12 July 2019.
Participants with a diagnosis of diabetic or idiopathic gastroparesis were enrolled and randomized in 1:1:1:1 ratio to receive TAK-954 0.1 mg, 0.3 mg, 1 mg or placebo.
Participant milestones
| Measure |
Placebo
TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.
|
TAK-954 0.1 mg
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
10
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.
|
TAK-954 0.1 mg
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=7 Participants
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 15.67 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
44.3 years
STANDARD_DEVIATION 12.45 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Disease History
Idiopathic Gastroparesis
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Disease History
Diabetic Gastroparesis
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Weight
|
68.3 kg
STANDARD_DEVIATION 15.05 • n=5 Participants
|
73.4 kg
STANDARD_DEVIATION 14.57 • n=7 Participants
|
76.5 kg
STANDARD_DEVIATION 17.97 • n=5 Participants
|
62.5 kg
STANDARD_DEVIATION 9.22 • n=4 Participants
|
70.6 kg
STANDARD_DEVIATION 15.07 • n=21 Participants
|
|
Height
|
166.2 cm
STANDARD_DEVIATION 9.37 • n=5 Participants
|
160.7 cm
STANDARD_DEVIATION 7.27 • n=7 Participants
|
165.7 cm
STANDARD_DEVIATION 5.92 • n=5 Participants
|
166.3 cm
STANDARD_DEVIATION 7.57 • n=4 Participants
|
164.6 cm
STANDARD_DEVIATION 7.74 • n=21 Participants
|
|
Body Mass Index (BMI)
|
24.8 kg/m^2
STANDARD_DEVIATION 4.88 • n=5 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.50 • n=7 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.44 • n=5 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 3.15 • n=4 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 5.24 • n=21 Participants
|
PRIMARY outcome
Timeframe: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2Population: Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
Outcome measures
| Measure |
Placebo
n=9 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=6 Participants
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
|
3.5 percent change
Standard Deviation 23.71
|
-19.8 percent change
Standard Deviation 14.43
|
-25.4 percent change
Standard Deviation 20.90
|
-25.7 percent change
Standard Deviation 23.56
|
SECONDARY outcome
Timeframe: 4, 24, and 48 hours post-radiolabeled meal on Day 2Population: Full analysis set included all randomized participants who received at least 1 dose of study drug. Number analyzed is the number of participants with evaluable data at the given time point.
The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.
Outcome measures
| Measure |
Placebo
n=10 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=7 Participants
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Colonic Geometric Center
Colonic Transit at 4 Hours, Day 2
|
0.539 score on a scale
Standard Deviation 0.6809
|
1.190 score on a scale
Standard Deviation 0.9083
|
1.737 score on a scale
Standard Deviation 1.0302
|
1.148 score on a scale
Standard Deviation 0.4138
|
|
Colonic Geometric Center
Colonic Transit at 24 Hours, Day 2
|
1.965 score on a scale
Standard Deviation 1.2964
|
3.792 score on a scale
Standard Deviation 1.1441
|
3.468 score on a scale
Standard Deviation 1.3252
|
2.978 score on a scale
Standard Deviation 1.1382
|
|
Colonic Geometric Center
Colonic Transit at 48 Hours, Day 2
|
3.323 score on a scale
Standard Deviation 1.2948
|
4.406 score on a scale
Standard Deviation 1.1169
|
4.550 score on a scale
Standard Deviation 0.9004
|
3.792 score on a scale
Standard Deviation 1.0382
|
SECONDARY outcome
Timeframe: 6 hours post-radiolabel meal on Day 2Population: Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.
Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.
Outcome measures
| Measure |
Placebo
n=9 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=6 Participants
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Colonic Filling at Hour 6
|
31.3 percentage of radio-labelled food
Standard Deviation 25.38
|
55.6 percentage of radio-labelled food
Standard Deviation 31.31
|
86.4 percentage of radio-labelled food
Standard Deviation 19.76
|
75.3 percentage of radio-labelled food
Standard Deviation 31.70
|
SECONDARY outcome
Timeframe: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3Population: Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analyses.
T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.
Outcome measures
| Measure |
Placebo
n=9 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=6 Participants
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Half-emptying Time (T1/2) of Ascending Colon
|
19.1 hours
Interval 2.6 to 36.0
|
5.4 hours
Interval 1.9 to 28.8
|
6.3 hours
Interval 0.6 to 11.0
|
7.4 hours
Interval 0.9 to 13.6
|
SECONDARY outcome
Timeframe: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Placebo
n=10 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=9 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=7 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Day 1
|
8.99 h*ng/mL
Standard Deviation 2.110
|
25.79 h*ng/mL
Standard Deviation 8.340
|
83.75 h*ng/mL
Standard Deviation 25.453
|
—
|
|
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Day 2
|
12.16 h*ng/mL
Standard Deviation 3.033
|
33.94 h*ng/mL
Standard Deviation 9.249
|
109.86 h*ng/mL
Standard Deviation 31.009
|
—
|
|
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Day 3
|
15.72 h*ng/mL
Standard Deviation 3.387
|
39.34 h*ng/mL
Standard Deviation 12.699
|
125.88 h*ng/mL
Standard Deviation 34.586
|
—
|
SECONDARY outcome
Timeframe: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3Population: PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Placebo
n=10 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=9 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=7 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954
Day 1
|
1.637 ng/mL
Standard Deviation 0.3918
|
5.346 ng/mL
Standard Deviation 1.5797
|
16.029 ng/mL
Standard Deviation 2.9239
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954
Day 2
|
1.687 ng/mL
Standard Deviation 0.4227
|
5.821 ng/mL
Standard Deviation 1.9447
|
15.517 ng/mL
Standard Deviation 3.7070
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954
Day 3
|
1.705 ng/mL
Standard Deviation 0.3297
|
5.056 ng/mL
Standard Deviation 1.5430
|
17.700 ng/mL
Standard Deviation 7.1544
|
—
|
SECONDARY outcome
Timeframe: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3Population: PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Placebo
n=10 Participants
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=9 Participants
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=7 Participants
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
Day 2
|
0.1969 ng/mL
Standard Deviation 0.05406
|
0.4364 ng/mL
Standard Deviation 0.20371
|
1.6817 ng/mL
Standard Deviation 0.47072
|
—
|
|
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
Day 3
|
0.2854 ng/mL
Standard Deviation 0.10319
|
0.6392 ng/mL
Standard Deviation 0.26371
|
2.2620 ng/mL
Standard Deviation 0.40493
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TAK-954 0.1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-954 0.3 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TAK-954 1 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 participants at risk
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 participants at risk
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=7 participants at risk
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.1 mg
n=10 participants at risk
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 0.3 mg
n=9 participants at risk
TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
TAK-954 1 mg
n=7 participants at risk
TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye swelling
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
4/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
2/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
3/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
10.0%
1/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER