Trial Outcomes & Findings for Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis (NCT NCT01703260)
NCT ID: NCT01703260
Last Updated: 2017-02-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2017-02-01
Participant Flow
Participants took part at 11 sites in the United States from 26 April 2013 to 30 September 2014.
Participants with a historical diagnosis of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) activity score (NAS) of greater than or equal to (\>=) 3 were enrolled in 1 of 3 treatment groups as follows: roflumilast + pioglitazone; roflumilast only; pioglitazone only.
Participant milestones
| Measure |
Roflumilast + Pioglitazone
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
Roflumilast + Pioglitazone
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Study Termination
|
1
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
Baseline characteristics by cohort
| Measure |
Roflumilast + Pioglitazone
n=7 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 14.77 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 10.93 • n=4 Participants
|
|
Age, Customized
18 - 39 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Age, Customized
40 - 59 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Age, Customized
60 - 80 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Height
|
165.6 centimeter (cm)
STANDARD_DEVIATION 15.13 • n=5 Participants
|
168.7 centimeter (cm)
STANDARD_DEVIATION 8.62 • n=7 Participants
|
174.3 centimeter (cm)
STANDARD_DEVIATION 7.50 • n=5 Participants
|
169.3 centimeter (cm)
STANDARD_DEVIATION 11.13 • n=4 Participants
|
|
Weight
|
102.19 kilogram (kg)
STANDARD_DEVIATION 21.041 • n=5 Participants
|
92.06 kilogram (kg)
STANDARD_DEVIATION 20.784 • n=7 Participants
|
110.15 kilogram (kg)
STANDARD_DEVIATION 15.456 • n=5 Participants
|
101.03 kilogram (kg)
STANDARD_DEVIATION 19.887 • n=4 Participants
|
|
Body Mass Index (BMI)
|
37.18 kilogram per square meter(kg/m^2)
STANDARD_DEVIATION 5.192 • n=5 Participants
|
32.19 kilogram per square meter(kg/m^2)
STANDARD_DEVIATION 6.189 • n=7 Participants
|
36.60 kilogram per square meter(kg/m^2)
STANDARD_DEVIATION 7.475 • n=5 Participants
|
35.26 kilogram per square meter(kg/m^2)
STANDARD_DEVIATION 6.381 • n=4 Participants
|
|
Smoking Classification
Had Never Smoked
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Smoking Classification
Current Smoker
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Smoking Classification
Ex-Smoker
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Type 2 Diabetes Mellitus
Had Diabetes Mellitus
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Type 2 Diabetes Mellitus
Did Not Have Diabetes Mellitus
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=7 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Amount of Serum Alanine Transaminase (ALT) at Baseline
|
101.7 international units per liter (IU/L)
Standard Deviation 56.98
|
83.4 international units per liter (IU/L)
Standard Deviation 31.63
|
118.8 international units per liter (IU/L)
Standard Deviation 36.76
|
PRIMARY outcome
Timeframe: Month 4Population: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.
The percent change between the serum ALT value collected at Month 4 or final visit relative to baseline.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=3 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=3 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=3 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Percent Change From Baseline in Serum ALT at Month 4
|
-53.89 percent change
Standard Deviation 23.362
|
-56.22 percent change
Standard Deviation 6.014
|
-28.86 percent change
Standard Deviation 53.298
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=7 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Amount of Serum Aspartate Transaminase (AST) at Baseline
|
64.0 IU/L
Standard Deviation 43.49
|
44.9 IU/L
Standard Deviation 15.25
|
88.3 IU/L
Standard Deviation 73.06
|
SECONDARY outcome
Timeframe: Month 4Population: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.
The percent change between the serum AST value collected at Month 4 or final visit relative to baseline.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=3 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=3 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=3 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Percent Change From Baseline in Serum AST at Month 4
|
-41.31 percent change
Standard Deviation 36.087
|
-43.20 percent change
Standard Deviation 7.339
|
-17.56 percent change
Standard Deviation 45.458
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.
Liver fat content was quantitatively measured by evaluating the percentage of proton density fat fraction (PDFF) from an abdominal magnetic resonance imaging (MRI). On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=7 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Liver Fat Content at Baseline
Caudate; (n= 6, 7, 6)
|
22.233 percentage of PDFF
Standard Deviation 8.2750
|
19.107 percentage of PDFF
Standard Deviation 7.7990
|
20.117 percentage of PDFF
Standard Deviation 9.8492
|
|
Liver Fat Content at Baseline
Left superolateral; (n= 6, 6, 6)
|
19.485 percentage of PDFF
Standard Deviation 8.8080
|
17.813 percentage of PDFF
Standard Deviation 7.4410
|
17.278 percentage of PDFF
Standard Deviation 7.2225
|
|
Liver Fat Content at Baseline
Left inferolateral; (n= 6, 7, 6)
|
22.385 percentage of PDFF
Standard Deviation 8.9894
|
19.747 percentage of PDFF
Standard Deviation 7.8306
|
19.153 percentage of PDFF
Standard Deviation 10.5909
|
|
Liver Fat Content at Baseline
Left superomedial: (n= 6, 7, 6)
|
22.115 percentage of PDFF
Standard Deviation 9.7126
|
20.426 percentage of PDFF
Standard Deviation 7.9170
|
20.100 percentage of PDFF
Standard Deviation 9.8688
|
|
Liver Fat Content at Baseline
Left inferomedial: (n= 6, 6, 6)
|
21.553 percentage of PDFF
Standard Deviation 9.5912
|
18.977 percentage of PDFF
Standard Deviation 8.6970
|
21.530 percentage of PDFF
Standard Deviation 9.5193
|
|
Liver Fat Content at Baseline
Right anteroinferior: (n= 6, 7, 6)
|
22.478 percentage of PDFF
Standard Deviation 9.0548
|
19.994 percentage of PDFF
Standard Deviation 9.0103
|
20.742 percentage of PDFF
Standard Deviation 8.7829
|
|
Liver Fat Content at Baseline
Right posteroinferior: (n= 6, 7, 6)
|
23.710 percentage of PDFF
Standard Deviation 8.6478
|
18.804 percentage of PDFF
Standard Deviation 6.6882
|
20.070 percentage of PDFF
Standard Deviation 9.9727
|
|
Liver Fat Content at Baseline
Right posterosuperior: (n= 6, 7, 6)
|
23.282 percentage of PDFF
Standard Deviation 9.5984
|
18.870 percentage of PDFF
Standard Deviation 7.5764
|
19.943 percentage of PDFF
Standard Deviation 8.9666
|
|
Liver Fat Content at Baseline
Right anterosuperior: (n=6, 7, 6)
|
23.630 percentage of PDFF
Standard Deviation 8.7454
|
19.786 percentage of PDFF
Standard Deviation 8.5929
|
21.527 percentage of PDFF
Standard Deviation 9.6648
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.
Liver fat content was quantitatively measured by evaluating the percentage of PDFF from an abdominal MRI. On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.
Outcome measures
| Measure |
Roflumilast + Pioglitazone
n=7 Participants
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 Participants
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 Participants
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Change From Baseline in Liver Fat Content at Month 4
Caudate; (n= 3, 3, 3)
|
-18.787 percent change in PDFF
Standard Deviation 11.5646
|
-11.590 percent change in PDFF
Standard Deviation 5.5674
|
-10.287 percent change in PDFF
Standard Deviation 8.8098
|
|
Change From Baseline in Liver Fat Content at Month 4
Left superolateral; (n= 6, 6, 6)
|
-15.170 percent change in PDFF
Standard Deviation 13.7442
|
-10.287 percent change in PDFF
Standard Deviation 1.9695
|
-8.067 percent change in PDFF
Standard Deviation 7.6318
|
|
Change From Baseline in Liver Fat Content at Month 4
Left inferolateral; (n= 3, 3, 3)
|
-14.290 percent change in PDFF
Standard Deviation 13.1654
|
-10.077 percent change in PDFF
Standard Deviation 2.9030
|
-8.773 percent change in PDFF
Standard Deviation 7.0821
|
|
Change From Baseline in Liver Fat Content at Month 4
Left superomedial: (n= 3, 3, 3)
|
-14.687 percent change in PDFF
Standard Deviation 13.6909
|
-11.177 percent change in PDFF
Standard Deviation 3.9429
|
-9.217 percent change in PDFF
Standard Deviation 8.7999
|
|
Change From Baseline in Liver Fat Content at Month 4
Left inferomedial: (n= 3, 3, 3)
|
-14.107 percent change in PDFF
Standard Deviation 15.2957
|
-10.977 percent change in PDFF
Standard Deviation 5.0052
|
-9.417 percent change in PDFF
Standard Deviation 8.9360
|
|
Change From Baseline in Liver Fat Content at Month 4
Right anteroinferior: (n= 3, 3, 3)
|
-13.990 percent change in PDFF
Standard Deviation 13.1266
|
-10.260 percent change in PDFF
Standard Deviation 6.9972
|
-7.693 percent change in PDFF
Standard Deviation 9.7985
|
|
Change From Baseline in Liver Fat Content at Month 4
Right posteroinferior: (n=3, 3, 3)
|
-18.073 percent change in PDFF
Standard Deviation 13.1470
|
-9.250 percent change in PDFF
Standard Deviation 1.6808
|
-8.790 percent change in PDFF
Standard Deviation 10.2188
|
|
Change From Baseline in Liver Fat Content at Month 4
Right posterosuperior: (n=3, 3, 3)
|
-17.717 percent change in PDFF
Standard Deviation 13.0691
|
-9.797 percent change in PDFF
Standard Deviation 4.4053
|
-8.113 percent change in PDFF
Standard Deviation 10.4166
|
|
Change From Baseline in Liver Fat Content at Month 4
Right anterosuperior: (n=3, 3, 3)
|
-16.127 percent change in PDFF
Standard Deviation 13.9820
|
-9.803 percent change in PDFF
Standard Deviation 3.3661
|
-8.647 percent change in PDFF
Standard Deviation 10.1658
|
Adverse Events
Roflumilast + Pioglitazone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Roflumilast Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pioglitazone Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Roflumilast + Pioglitazone
n=7 participants at risk
Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
|
Roflumilast Only
n=7 participants at risk
Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
|
Pioglitazone Only
n=6 participants at risk
Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
28.6%
2/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
General disorders
Chills
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
33.3%
2/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Metabolism and nutrition disorders
Cow's milk intolerance
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
2/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
28.6%
2/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
33.3%
2/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Nervous system disorders
Sciatica
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
14.3%
1/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
0.00%
0/7 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
16.7%
1/6 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the first dose of double-blinded study drug and no more than 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 treatment.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER