Trial Outcomes & Findings for A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery (NCT NCT03943446)
NCT ID: NCT03943446
Last Updated: 2023-09-07
Results Overview
Endoscopic recurrence (ER) is defined as a Rutgeerts' score ≥ i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The total score ranges from i0 to i4; where i0 = no lesions, i1= ≤ 5 aphthous ulcers, i2= \> 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing. Higher score indicates worsening. Percentages are rounded off to the nearest single decimal.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
At Week 26
Results posted on
2023-09-07
Participant Flow
Participants took part in the study at 18 investigative sites in the United States, Australia, Germany, France and United Kingdom from 4 August 2020 to 25 August 2022.
Participants with Crohn's disease (CD) who had undergone a planned laparoscopic ileocecal resection received TAK-018 for prevention of the recurrence of postoperative CD. The participants were randomized in 1:1:1 ratio to three treatment groups i.e. TAK-018 low dose, TAK-018 high dose, or placebo for a 26-week treatment period.
Participant milestones
| Measure |
Placebo
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
|
Overall Study
Pharmacokinetic (PK) Analysis Set
|
12
|
11
|
11
|
|
Overall Study
COMPLETED
|
5
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
2
|
1
|
|
Overall Study
Reason not Specified
|
5
|
1
|
3
|
Baseline Characteristics
A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=11 Participants
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
n=11 Participants
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.97 years
STANDARD_DEVIATION 13.133 • n=39 Participants
|
37.42 years
STANDARD_DEVIATION 16.179 • n=41 Participants
|
39.25 years
STANDARD_DEVIATION 11.297 • n=35 Participants
|
39.97 years
STANDARD_DEVIATION 13.457 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Height
|
171.87 centimeters (cm)
STANDARD_DEVIATION 7.709 • n=39 Participants
|
167.95 centimeters (cm)
STANDARD_DEVIATION 7.692 • n=41 Participants
|
172.57 centimeters (cm)
STANDARD_DEVIATION 8.594 • n=35 Participants
|
170.83 centimeters (cm)
STANDARD_DEVIATION 8.019 • n=31 Participants
|
|
Weight
|
72.44 kilograms (kg)
STANDARD_DEVIATION 13.514 • n=39 Participants
|
67.61 kilograms (kg)
STANDARD_DEVIATION 15.111 • n=41 Participants
|
77.95 kilograms (kg)
STANDARD_DEVIATION 19.971 • n=35 Participants
|
72.66 kilograms (kg)
STANDARD_DEVIATION 16.394 • n=31 Participants
|
|
Body Mass Index (BMI)
|
24.57 kilogram per meters squared (kg/m^2)
STANDARD_DEVIATION 4.617 • n=39 Participants
|
23.92 kilogram per meters squared (kg/m^2)
STANDARD_DEVIATION 5.037 • n=41 Participants
|
26.09 kilogram per meters squared (kg/m^2)
STANDARD_DEVIATION 6.175 • n=35 Participants
|
24.85 kilogram per meters squared (kg/m^2)
STANDARD_DEVIATION 5.214 • n=31 Participants
|
PRIMARY outcome
Timeframe: At Week 26Population: FAS included all participants to whom study treatment had been assigned by randomization and received at least 1 dose of study drug.
Endoscopic recurrence (ER) is defined as a Rutgeerts' score ≥ i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The total score ranges from i0 to i4; where i0 = no lesions, i1= ≤ 5 aphthous ulcers, i2= \> 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing. Higher score indicates worsening. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
Placebo
n=12 Participants
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=11 Participants
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
n=11 Participants
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26
|
91.7 percentage of participants
|
81.8 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 3, 6, 12, 18, 26 and 30Population: FAS included all participants to whom study treatment had been assigned by randomization and received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates number of participants available for analysis at the given timepoints.
Stool samples were collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
Placebo
n=11 Participants
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=8 Participants
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
n=7 Participants
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 3
|
55.6 percentage of participants
|
75.0 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 6
|
27.3 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 12
|
44.4 percentage of participants
|
37.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 18
|
75.0 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 26
|
71.4 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
At Week 30
|
40.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 12 hours) post-dose at Week 3Population: Pharmacokinetic (PK) analysis set included participants from the safety analysis set with at least 1 reported PK concentration. Overall number of participants analyzed is the number of participants available for analyses.
Outcome measures
| Measure |
Placebo
n=9 Participants
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=5 Participants
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Ctrough: Observed Plasma Trough Concentrations of TAK-018
|
13.8 milligrams per Litre (mg/L)
Standard Deviation 9.39
|
36.2 milligrams per Litre (mg/L)
Standard Deviation 21.7
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
TAK-018 0.30 g Low Dose
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
TAK-018 1.5 g High Dose
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
TAK-018 placebo-matching tablets, orally, BID for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=11 participants at risk
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
n=11 participants at risk
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Abdominal wound dehiscence
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Anastomotic leak
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Blood loss anaemia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Inflammation
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Mesenteric haemorrhage
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Subileus
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Varices oesophageal
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
TAK-018 placebo-matching tablets, orally, BID for up to 27.7 weeks.
|
TAK-018 0.30 g Low Dose
n=11 participants at risk
TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
|
TAK-018 1.5 g High Dose
n=11 participants at risk
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
2/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 upper
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 tenderness
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Alopecia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Blood phosphorus decreased
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Bowel movement irregularity
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
C-reactive protein increased
|
25.0%
3/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
COVID-19
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Crohn's disease
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Depression
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Dermatitis contact
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Escherichia urinary tract infection
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Faecal calprotectin increased
|
25.0%
3/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Gastritis
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Haematocrit decreased
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Haemoglobin decreased
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Hepatic enzyme increased
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Iron deficiency anaemia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Lymphopenia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle tightness
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle twitching
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
25.0%
3/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Neuralgia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Peripheral swelling
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Platelet count increased
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Post procedural discomfort
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Procedural pain
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Rash
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Red blood cell count decreased
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Respiratory tract infection
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Sensitive skin
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Sepsis
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Thrombocytopenia
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Tinea versicolour
|
0.00%
0/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
Tremor
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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
|
41.7%
5/12 • From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and 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 drug up to 30 days following last dose of study drug (up to 35.98 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER