Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935 (NCT NCT02201056)
NCT ID: NCT02201056
Last Updated: 2016-07-12
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1 to Day 30
Results posted on
2016-07-12
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 09 July 2014 to 30 July 2015.
Healthy Volunteers were enrolled in 1 of 7 treatment groups, once a day placebo, TAK 935 15 mg, 50 mg, 200 mg, 600 mg, 900 mg or 1350 mg.
Participant milestones
| Measure |
Cohorts 1-6: Placebo
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Baseline characteristics by cohort
| Measure |
Cohorts 1-6: Placebo
n=12 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 Participants
TAK-935 1350 mg solution, orally, once, on Day 1.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 10.41 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 8.21 • n=107 Participants
|
34.3 years
STANDARD_DEVIATION 10.93 • n=206 Participants
|
29.8 years
STANDARD_DEVIATION 6.74 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 13.31 • n=31 Participants
|
30.5 years
STANDARD_DEVIATION 10.33 • n=30 Participants
|
32.8 years
STANDARD_DEVIATION 12.97 • n=3 Participants
|
33.6 years
STANDARD_DEVIATION 10.15 • n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
2 participants
n=31 Participants
|
2 participants
n=30 Participants
|
1 participants
n=3 Participants
|
8 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
6 participants
n=7 Participants
|
3 participants
n=31 Participants
|
4 participants
n=30 Participants
|
5 participants
n=3 Participants
|
39 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
1 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
4 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
11 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
44 participants
n=6 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
48 participants
n=6 Participants
|
|
Height
|
170.8 cm
STANDARD_DEVIATION 5.99 • n=99 Participants
|
165.0 cm
STANDARD_DEVIATION 11.52 • n=107 Participants
|
175.0 cm
STANDARD_DEVIATION 5.59 • n=206 Participants
|
178.7 cm
STANDARD_DEVIATION 7.31 • n=7 Participants
|
173.5 cm
STANDARD_DEVIATION 8.89 • n=31 Participants
|
161.5 cm
STANDARD_DEVIATION 2.88 • n=30 Participants
|
165.5 cm
STANDARD_DEVIATION 2.59 • n=3 Participants
|
170.1 cm
STANDARD_DEVIATION 8.43 • n=6 Participants
|
|
Weight
|
70.23 kg
STANDARD_DEVIATION 10.478 • n=99 Participants
|
68.88 kg
STANDARD_DEVIATION 19.873 • n=107 Participants
|
78.25 kg
STANDARD_DEVIATION 13.623 • n=206 Participants
|
80.18 kg
STANDARD_DEVIATION 12.039 • n=7 Participants
|
76.85 kg
STANDARD_DEVIATION 9.465 • n=31 Participants
|
70.10 kg
STANDARD_DEVIATION 6.214 • n=30 Participants
|
69.28 kg
STANDARD_DEVIATION 10.981 • n=3 Participants
|
73.00 kg
STANDARD_DEVIATION 12.178 • n=6 Participants
|
|
Body Mass Index (BMI)
|
24.00 kg/m^2
STANDARD_DEVIATION 2.532 • n=99 Participants
|
24.86 kg/m^2
STANDARD_DEVIATION 4.073 • n=107 Participants
|
25.44 kg/m^2
STANDARD_DEVIATION 3.361 • n=206 Participants
|
25.05 kg/m^2
STANDARD_DEVIATION 3.039 • n=7 Participants
|
25.51 kg/m^2
STANDARD_DEVIATION 2.539 • n=31 Participants
|
26.88 kg/m^2
STANDARD_DEVIATION 2.313 • n=30 Participants
|
25.34 kg/m^2
STANDARD_DEVIATION 4.251 • n=3 Participants
|
25.13 kg/m^2
STANDARD_DEVIATION 3.064 • n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 30Population: Safety set included all participants who were enrolled and received study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=12 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 Participants
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
|
41.7 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
83.3 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Safety set included all participants who were enrolled and received study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=12 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 Participants
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Safety set included all participants who were enrolled and received study drug.
The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=12 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 Participants
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose
|
75.0 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Safety set included all participants who were enrolled and received study drug.
The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=12 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 Participants
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose
|
25.0 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Multiple time-points (Up to 96 hours) post-dosePopulation: Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=6 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-935
|
43.533 ng/mL
Standard Deviation 41.2350
|
210.150 ng/mL
Standard Deviation 153.0463
|
571.167 ng/mL
Standard Deviation 257.8002
|
4551.667 ng/mL
Standard Deviation 2573.5067
|
5080.000 ng/mL
Standard Deviation 1801.9323
|
7953.333 ng/mL
Standard Deviation 2151.3035
|
—
|
SECONDARY outcome
Timeframe: Multiple time-points (Up to 96 hours) post-dosePopulation: PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=6 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
|
33.323 ng*hr/mL
Standard Deviation 28.9569
|
168.736 ng*hr/mL
Standard Deviation 88.3702
|
562.660 ng*hr/mL
Standard Deviation 196.6517
|
5791.561 ng*hr/mL
Standard Deviation 3427.9888
|
7619.088 ng*hr/mL
Standard Deviation 1928.2091
|
13501.049 ng*hr/mL
Standard Deviation 5778.0847
|
—
|
SECONDARY outcome
Timeframe: Multiple time-points (Up to 96 hours) post-dosePopulation: PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.
Outcome measures
| Measure |
Cohorts 1-6: Placebo
n=3 Participants
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=4 Participants
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=3 Participants
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 Participants
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
|
23.290 ng*hr/mL
Standard Deviation 6.7061
|
172.430 ng*hr/mL
Standard Deviation 107.0799
|
621.369 ng*hr/mL
Standard Deviation 240.5953
|
5809.066 ng*hr/mL
Standard Deviation 3427.5393
|
7660.961 ng*hr/mL
Standard Deviation 1962.0905
|
13541.772 ng*hr/mL
Standard Deviation 5763.4722
|
—
|
Adverse Events
Cohorts 1-6: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: TAK-935 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: TAK-935 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: TAK-935 200 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: TAK-935 600 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5: TAK-935 900 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6: TAK-935 1350 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1-6: Placebo
n=12 participants at risk
TAK-935 placebo-matching solution, orally, once, on Day 1.
|
Cohort 1: TAK-935 15 mg
n=6 participants at risk
TAK-935 15 mg solution, orally, once, on Day 1.
|
Cohort 2: TAK-935 50 mg
n=6 participants at risk
TAK-935 50 mg solution, orally, once, on Day 1.
|
Cohort 3: TAK-935 200 mg
n=6 participants at risk
TAK-935 200 mg solution, orally, once, on Day 1.
|
Cohort 4: TAK-935 600 mg
n=6 participants at risk
TAK-935 600 mg solution, orally, once, on Day 1.
|
Cohort 5: TAK-935 900 mg
n=6 participants at risk
TAK-935 900 mg solution, orally, once, on Day 1.
|
Cohort 6: TAK-935 1350 mg
n=6 participants at risk
TAK-935 1350 mg solution, orally, once, on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Application site dermatitis
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Application site erosion
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Application site erythema
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Application site pruritus
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Thirst
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
General disorders
Fatigue
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Injury, poisoning and procedural complications
Laceration
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
33.3%
2/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Nervous system disorders
Disturbance in attention
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Psychiatric disorders
Abnormal dreams
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
16.7%
1/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
8.3%
1/12 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
|
0.00%
0/6 • 30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER