Trial Outcomes & Findings for A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants. (NCT NCT00942175)
NCT ID: NCT00942175
Last Updated: 2012-02-03
Results Overview
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
160 participants
Primary outcome timeframe
Day 9 of each period
Results posted on
2012-02-03
Participant Flow
Participants enrolled at one site in the United States from 15 December 2009 to 08 July 2010.
Healthy participants were enrolled in one of 4, once-daily (QD), proton pump inhibitor (PPI) treatment groups.
Participant milestones
| Measure |
PPI Group 1
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
PPI Group 1
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Elevated Alanine Amino Transferase
|
0
|
0
|
0
|
1
|
|
Overall Study
Low Platelet Count
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants.
Baseline characteristics by cohort
| Measure |
PPI Group 1
n=40 Participants
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2
n=40 Participants
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3
n=40 Participants
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4
n=40 Participants
Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
32.8 years
STANDARD_DEVIATION 6.48 • n=93 Participants
|
35.7 years
STANDARD_DEVIATION 7.92 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 7.40 • n=27 Participants
|
33.3 years
STANDARD_DEVIATION 7.10 • n=483 Participants
|
33.9 years
STANDARD_DEVIATION 7.26 • n=36 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
80 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
80 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 9 of each periodPopulation: All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
PPI Group 1: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.
|
39.14 ng/mL
Standard Deviation 12.553
|
30.01 ng/mL
Standard Deviation 15.264
|
38.85 ng/mL
Standard Deviation 15.699
|
29.33 ng/mL
Standard Deviation 12.400
|
38.25 ng/mL
Standard Deviation 12.461
|
22.55 ng/mL
Standard Deviation 10.682
|
40.98 ng/mL
Standard Deviation 22.908
|
24.69 ng/mL
Standard Deviation 10.641
|
PRIMARY outcome
Timeframe: Day 9 of each periodPopulation: All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.
Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
PPI Group 1: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.
|
41.69 ng*hr/ML
Standard Deviation 10.020
|
36.42 ng*hr/ML
Standard Deviation 10.825
|
41.25 ng*hr/ML
Standard Deviation 14.690
|
37.75 ng*hr/ML
Standard Deviation 13.132
|
37.78 ng*hr/ML
Standard Deviation 12.043
|
26.28 ng*hr/ML
Standard Deviation 8.800
|
42.35 ng*hr/ML
Standard Deviation 18.785
|
31.23 ng*hr/ML
Standard Deviation 9.938
|
PRIMARY outcome
Timeframe: 24-hour post Day 9 dose in each period.Population: All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.
PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).
Outcome measures
| Measure |
PPI Group 1: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
|
42.3 percent inhibition
Standard Deviation 14.61
|
46.4 percent inhibition
Standard Deviation 16.44
|
41.3 percent inhibition
Standard Deviation 15.45
|
43.0 percent inhibition
Standard Deviation 16.47
|
47.9 percent inhibition
Standard Deviation 15.70
|
59.1 percent inhibition
Standard Deviation 17.87
|
46.5 percent inhibition
Standard Deviation 17.28
|
58.0 percent inhibition
Standard Deviation 14.64
|
PRIMARY outcome
Timeframe: 24-hour post Day 9 dose in each period.Population: All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.
Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.
Outcome measures
| Measure |
PPI Group 1: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=37 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=37 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
|
28.1 percentage of MPA
Standard Deviation 6.76
|
30.8 percentage of MPA
Standard Deviation 9.35
|
34.6 percentage of MPA
Standard Deviation 14.23
|
36.2 percentage of MPA
Standard Deviation 16.87
|
34.2 percentage of MPA
Standard Deviation 12.32
|
42.5 percentage of MPA
Standard Deviation 14.74
|
29.3 percentage of MPA
Standard Deviation 10.41
|
38.2 percentage of MPA
Standard Deviation 17.77
|
PRIMARY outcome
Timeframe: 24-hour post Day 9 dose in each period.Population: All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.
MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.
Outcome measures
| Measure |
PPI Group 1: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=36 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=37 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=37 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=38 Participants
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
|
36.7 percentage of MPA
Standard Deviation 9.11
|
41.6 percentage of MPA
Standard Deviation 12.65
|
43.1 percentage of MPA
Standard Deviation 13.24
|
46.3 percentage of MPA
Standard Deviation 16.93
|
43.5 percentage of MPA
Standard Deviation 14.00
|
53.5 percentage of MPA
Standard Deviation 13.75
|
39.3 percentage of MPA
Standard Deviation 13.22
|
47.9 percentage of MPA
Standard Deviation 15.77
|
Adverse Events
PPI Group 1: Regimen A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PPI Group 1: Regimen B
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
PPI Group 2: Regimen A
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
PPI Group 2: Regimen C
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
PPI Group 3: Regimen A
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PPI Group 3: Regimen D
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PPI Group 4: Regimen A
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
PPI Group 4: Regimen E
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPI Group 1: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=38 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=38 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Serum sickness-like reaction
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
Other adverse events
| Measure |
PPI Group 1: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 1: Regimen B
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 2: Regimen C
n=38 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen A
n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 3: Regimen D
n=38 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen A
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
|
PPI Group 4: Regimen E
n=39 participants at risk；n=40 participants at risk
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
12.8%
5/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
General disorders
Feeling Hot
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
10.3%
4/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
12.8%
5/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
18.4%
7/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
15.8%
6/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
15.4%
6/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
10.3%
4/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.9%
3/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
10.0%
4/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.9%
3/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Nervous system disorders
Somnolence
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
10.3%
4/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
7.7%
3/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.3%
2/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
10.3%
4/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.6%
1/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/38 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
5.1%
2/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
0.00%
0/39 • Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
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 therefrom or any data, information or materials obtained or generated in the performance of it's 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