Trial Outcomes & Findings for Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes (NCT NCT01664624)
NCT ID: NCT01664624
Last Updated: 2017-02-01
Results Overview
The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).
Results posted on
2017-02-01
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 10 July 2012 to 29 November 2012.
Participants with a diagnosis of type 2 diabetes mellitus and inadequate glycemic control were enrolled equally in 1 of 4 treatment groups, roflumilast + alogliptin, alogliptin alone, roflumilast alone, or exenatide.
Participant milestones
| Measure |
Roflumilast + Alogliptin
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Roflumilast + Alogliptin
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
Baseline characteristics by cohort
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=11 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 10.15 • n=99 Participants
|
52.9 years
STANDARD_DEVIATION 7.52 • n=107 Participants
|
60.7 years
STANDARD_DEVIATION 4.24 • n=206 Participants
|
54.6 years
STANDARD_DEVIATION 6.88 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 8.15 • n=31 Participants
|
|
Age, Customized
< 65 years
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
9 participants
n=206 Participants
|
9 participants
n=7 Participants
|
39 participants
n=31 Participants
|
|
Age, Customized
≥ 65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Gender
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Gender
Male
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
6 participants
n=7 Participants
|
26 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
14 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
8 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
9 participants
n=7 Participants
|
32 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
10 participants
n=206 Participants
|
9 participants
n=7 Participants
|
40 participants
n=31 Participants
|
|
Height
|
171.1 cm
STANDARD_DEVIATION 8.91 • n=99 Participants
|
171.2 cm
STANDARD_DEVIATION 6.03 • n=107 Participants
|
166.6 cm
STANDARD_DEVIATION 10.44 • n=206 Participants
|
166.4 cm
STANDARD_DEVIATION 5.90 • n=7 Participants
|
169.0 cm
STANDARD_DEVIATION 8.09 • n=31 Participants
|
|
Weight
|
103.12 kg
STANDARD_DEVIATION 21.688 • n=99 Participants
|
93.24 kg
STANDARD_DEVIATION 11.670 • n=107 Participants
|
89.33 kg
STANDARD_DEVIATION 17.961 • n=206 Participants
|
86.98 kg
STANDARD_DEVIATION 14.713 • n=7 Participants
|
93.32 kg
STANDARD_DEVIATION 17.329 • n=31 Participants
|
|
Body Mass Index (BMI)
|
34.93 kg/m^2
STANDARD_DEVIATION 4.708 • n=99 Participants
|
31.75 kg/m^2
STANDARD_DEVIATION 3.184 • n=107 Participants
|
32.03 kg/m^2
STANDARD_DEVIATION 5.311 • n=206 Participants
|
31.37 kg/m^2
STANDARD_DEVIATION 4.653 • n=7 Participants
|
32.53 kg/m^2
STANDARD_DEVIATION 4.548 • n=31 Participants
|
|
Smoking Classification
Never smoked
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
7 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
Smoking Classification
Current smoker
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Smoking Classification
Ex-smoker
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
10 participants
n=31 Participants
|
|
Duration of Diabetes
|
6.9 years
STANDARD_DEVIATION 4.63 • n=99 Participants
|
8.5 years
STANDARD_DEVIATION 6.39 • n=107 Participants
|
7.0 years
STANDARD_DEVIATION 3.86 • n=206 Participants
|
8.2 years
STANDARD_DEVIATION 6.63 • n=7 Participants
|
7.7 years
STANDARD_DEVIATION 5.33 • n=31 Participants
|
|
Metformin Dose
|
875.0 mg
STANDARD_DEVIATION 151.38 • n=99 Participants
|
745.0 mg
STANDARD_DEVIATION 225.40 • n=107 Participants
|
805.0 mg
STANDARD_DEVIATION 220.42 • n=206 Participants
|
855.6 mg
STANDARD_DEVIATION 211.31 • n=7 Participants
|
819.2 mg
STANDARD_DEVIATION 202.49 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).Population: Full analysis set defined as all randomized participants included in the safety analysis. Only participants with data at both Baseline and post-baseline visits are included.
The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1
|
26.5 pmol/L*hr
Standard Error 4.04
|
31.6 pmol/L*hr
Standard Error 4.01
|
3.8 pmol/L*hr
Standard Error 3.94
|
-2.3 pmol/L*hr
Standard Error 4.14
|
SECONDARY outcome
Timeframe: Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).Population: Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.
The concentration of glucose in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and baseline postprandial AUC (0-8) of plasma glucose as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose
|
-13.4 mmol/L*hr
Standard Error 2.70
|
-9.8 mmol/L*hr
Standard Error 2.71
|
-9.0 mmol/L*hr
Standard Error 2.71
|
-18.5 mmol/L*hr
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).Population: Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.
The concentration of C-peptide in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of C-peptide as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline in Postprandial AUC(0-8) of C-peptide
|
1.0 ng/mL*hr
Standard Error 1.15
|
1.4 ng/mL*hr
Standard Error 1.16
|
-0.7 ng/mL*hr
Standard Error 1.17
|
0.0 ng/mL*hr
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).Population: Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.
The concentration of insulin in blood before and up to 8 hours after eating was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of insulin as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline in Postprandial AUC(0-8) of Insulin
|
-49.5 pmol/L*hr
Standard Error 181.09
|
107.8 pmol/L*hr
Standard Error 180.75
|
26.9 pmol/L*hr
Standard Error 180.38
|
-136.4 pmol/L*hr
Standard Error 190.12
|
SECONDARY outcome
Timeframe: At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal.Population: Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.
Appetite sensations were measured using a visual analog scale (VAS) questionnaire. Participants were asked to indicate their level of fullness, hunger, satiety, and prospective consumption (how much do you think you can eat?) on a 100 mm line ranging from "Not at all" (0 mm) to "extremely" (100 mm). Appetite sensation scores before and up to 8 hours after eating were plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of appetite sensation VAS score as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation
Fullness
|
70.5 mm*hr
Standard Error 59.73
|
62.0 mm*hr
Standard Error 56.52
|
136.0 mm*hr
Standard Error 57.81
|
116.8 mm*hr
Standard Error 59.51
|
|
Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation
Hunger
|
-103.6 mm*hr
Standard Error 52.61
|
3.1 mm*hr
Standard Error 52.18
|
-132.7 mm*hr
Standard Error 52.44
|
-122.5 mm*hr
Standard Error 54.92
|
|
Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation
Prospective consumption
|
-97.1 mm*hr
Standard Error 54.24
|
-14.9 mm*hr
Standard Error 53.76
|
-169.5 mm*hr
Standard Error 53.98
|
-124.3 mm*hr
Standard Error 56.53
|
|
Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation
Satiety
|
-82.7 mm*hr
Standard Error 53.66
|
-3.2 mm*hr
Standard Error 52.96
|
-139.2 mm*hr
Standard Error 53.58
|
-127.7 mm*hr
Standard Error 55.80
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11, from 12 AM through 24 hours.Population: Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.
Plasma glucose was measured by Continuous Glucose Monitoring System (CGMS). CGMS measures glucose every 5 minutes, starting in the fasting state 8 hour prior to the standardized breakfast (12 AM) until 16 hours after the breakfast. The average 24-hour plasma glucose concentration was calculated. Least squares means were obtained using an ANCOVA model with treatment as fixed effect, and Baseline 24-hour Glucose Measured by CGMS as a continuous covariate.
Outcome measures
| Measure |
Roflumilast + Alogliptin
n=10 Participants
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=10 Participants
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 Participants
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 Participants
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Change From Baseline to Day 11 in 24-hour Average Plasma Glucose
|
-25.4 mg/dL
Standard Error 6.67
|
-17.5 mg/dL
Standard Error 6.67
|
-14.5 mg/dL
Standard Error 6.66
|
-34.9 mg/dL
Standard Error 7.02
|
Adverse Events
Roflumilast + Alogliptin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Alogliptin Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Roflumilast Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Exenatide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Roflumilast + Alogliptin
n=10 participants at risk
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=11 participants at risk
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 participants at risk
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 participants at risk
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Roflumilast + Alogliptin
n=10 participants at risk
Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
|
Alogliptin Alone
n=11 participants at risk
Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
|
Roflumilast Alone
n=10 participants at risk
Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
|
Exenatide
n=9 participants at risk
Exenatide 5 μg subcutaneous injection twice a day for 11 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
4/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
44.4%
4/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
5/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
10.0%
1/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From the first dose of study medication to no more than 30 days after the last dose of the study medication (a maximum of 41 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca
Phone: 1-877-240-9479
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 its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER