Trial Outcomes & Findings for A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) (NCT NCT02993783)
NCT ID: NCT02993783
Last Updated: 2019-05-24
Results Overview
CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving \<25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration \<2 mg/dL or \<25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Day 28
Results posted on
2019-05-24
Participant Flow
Participants took part in the study at 11 investigative sites in the United States, France, Belgium and Norway from 28 April 2017 to 09 May 2018.
Participants with steroid-refractory acute intestinal graft-versus-host disease (GvHD) who had undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) were enrolled to receive 300 mg or 600 mg vedolizumab.
Participant milestones
| Measure |
Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Overall Study
Reason not Specified
|
6
|
9
|
Baseline Characteristics
Data for Height is not available for 1 participant from SAS.
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 10.45 • n=8 Participants
|
59.0 years
STANDARD_DEVIATION 10.87 • n=9 Participants
|
56.7 years
STANDARD_DEVIATION 10.64 • n=17 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
4 Participants
n=9 Participants
|
10 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
16 Participants
n=17 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
|
Region of Enrollment
Norway
|
0 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=8 Participants
|
5 Participants
n=9 Participants
|
8 Participants
n=17 Participants
|
|
Height
|
170.3 cm
STANDARD_DEVIATION 12.08 • n=8 Participants • Data for Height is not available for 1 participant from SAS.
|
169.8 cm
STANDARD_DEVIATION 7.87 • n=8 Participants • Data for Height is not available for 1 participant from SAS.
|
170.0 cm
STANDARD_DEVIATION 9.85 • n=16 Participants • Data for Height is not available for 1 participant from SAS.
|
|
Weight
|
76.40 kg
STANDARD_DEVIATION 16.900 • n=8 Participants
|
74.01 kg
STANDARD_DEVIATION 22.255 • n=9 Participants
|
75.14 kg
STANDARD_DEVIATION 19.342 • n=17 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Status
0
|
2 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Status
1
|
3 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
5 Participants
n=17 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Status
2
|
1 Participants
n=8 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=17 Participants
|
|
Baseline Eastern Cooperative Oncology Group (ECOG) Status
3
|
2 Participants
n=8 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving \<25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration \<2 mg/dL or \<25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
PRIMARY outcome
Timeframe: From first dose up to Day 28Population: SAS included all participants who received any amount of the study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
88.9 percentage of participants
Interval 68.4 to 100.0
|
SECONDARY outcome
Timeframe: Day 28Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
CR is defined as the resolution of all signs and symptoms of acute GvHD.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 28Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
Symptoms of acute intestinal GvHD were measured using the BMT CTN-modified International Bone Marrow Transplant Registry Database (IBMTR) index. Intestinal overall response is either CR, VGPR or PR for intestine only. CR is defined as the resolution of all signs and symptoms of GvHD. VGPR is defined as resolution of the majority of signs and symptoms of intestinal GvHD: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of intestinal GvHD by at least 1 stage.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Percentage of Participants With Intestinal Overall Response at Day 28
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12
Month 6
|
0.50 percentage of participants
Interval 0.15 to 0.77
|
0.11 percentage of participants
Interval 0.01 to 0.39
|
|
Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12
Month 12
|
NA percentage of participants
Percentage and 95% CI was not reached due to low number of participants with events.
|
NA percentage of participants
Percentage and 95% CI was not reached due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12
Month 12
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12
Month 6
|
37.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Months 6 and 12Population: Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.
Total Steroids administered in mg/kg/day of methylprednisolone or equivalent
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Total Dose of Steroids Administered
Month 6
|
0.862 mg/kg/day
Standard Deviation 0.6397
|
0.876 mg/kg/day
Standard Deviation 0.4796
|
|
Total Dose of Steroids Administered
Month 12
|
0.829 mg/kg/day
Standard Deviation 0.6611
|
0.876 mg/kg/day
Standard Deviation 0.4798
|
SECONDARY outcome
Timeframe: From first dose of study drug to 18 weeks after last dose (Up to Week 32)Population: SAS included all participants who received any amount of the study drug.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to 18 weeks after last dose (Up to Week 32)Population: SAS included all participants who received any amount of the study drug.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to last dose of study drug (Day 99)Population: SAS included all participants who received any amount of the study drug.
Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)\>3.0 U/L\*upper limit of normal(ULN),albumin\<25 g/L\*lower limit of normal(LLN),alkaline phosphatase \>3.0 U/L\*ULN,aspartate aminotransferase \>3.0 U/L\*ULN,bilirubin \>2 umol/L\*ULN,blood urea nitrogen(BUN) \>10.7 mmol/L,calcium \<1.75 mmol/L, \>2.88 mmol/L,chloride \<75 mmol/L, \>126 mmol/L,creatinine \>177umol/L,gamma glutamyl transferase (GGT) \>3 U/L\*ULN,glucose \<2.8 mmol/L, \>19.4 mmol/L,phosphate \<0.52 mmol/L, \>2.10 mmol/L,potassium\<3 mmol/L, \>6 mmol/L,sodium \<130 mmol/L, \>150 mmol/L,basophils \>3(10\^9/L)\*ULN,eosinophils \>2(10\^9/L)\*ULN,hematocrit (%) \<0.8\*LLN, \>1.2\*ULN,hemoglobin \<0.8 g/L\*LLN, \>1.2 g/L\*ULN,leukocytes \<0.5 (10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN,lymphocytes \<0.5 (10\^9/L)\*LLN, \>1.5(10\^9/L)\*ULN,monocytes \>2 (10\^9/L)\*ULN,neutrophils \<0.5(10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN,platelets \<75(10\^9/L), \>600(10\^9/L).
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
ALT >3.0 U/L*ULN
|
4 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Albumin <25 g/L*LLN
|
4 Participants
|
8 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Alkaline phosphatase >3.0 U/L*ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Aspartate aminotransferase >3.0 U/L*ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Bilirubin >2 umol/L*ULN
|
1 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
BUN >10.7 mmol/L
|
3 Participants
|
6 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Calcium <1.75 mmol/L
|
0 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Calcium >2.88 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Chloride <75 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Chloride >126 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Creatinine >177umol/L
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
GGT >3 U/L*ULN
|
5 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Glucose <2.8 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Glucose >19.4 mmol/L
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Phosphate <0.52 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Phosphate >2.10 mmol/L
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Potassium <3 mmol/L
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Potassium >6 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Sodium <130 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Sodium >150 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Basophils >3(10^9/L)*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Eosinophils >2(10^9/L)*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hematocrit (%) <0.8*LLN
|
7 Participants
|
8 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hematocrit (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hemoglobin <0.8 g/L*LLN
|
7 Participants
|
8 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hemoglobin >1.2 g/L*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Leukocytes <0.5 (10^9/L)*LLN
|
3 Participants
|
7 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Leukocytes >1.5 (10^9/L)*ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Lymphocytes <0.5 (10^9/L)*LLN
|
7 Participants
|
9 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Lymphocytes >1.5(10^9/L)*ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Monocytes >2 (10^9/L)*ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Neutrophils <0.5(10^9/L)*LLN
|
0 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Neutrophils >1.5 (10^9/L)*ULN
|
1 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Platelets <75(10^9/L)
|
8 Participants
|
9 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Platelets >600(10^9/L)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to last dose of study drug (Day 99)Population: SAS included all participants who received any amount of the study drug.
Vital signs included heart rate, respiratory rate, systolic and diastolic blood pressure, temperature and weight. The vital sign values outside the range: systolic blood pressure (SBP) \<85 mmHg and change from Baseline (BL) \<=-20 mmHg, \>180 mmHg and change from Baseline \>=20 mmHg,diastolic blood pressure (DBP) \<50 mmHg and change from Baseline \<=-15 mmHg, \>110 mmHg and change from Baseline \>=15 mmHg, heart rate \<50 beats per minute (bpm),\>120 beats per minute, temperature \<35.6 Degree C, \>37.7 Degree C and weight change from Baseline \<=-7 % and weight change from Baseline \>=7 % assessed during treatment period were considered markedly abnormal.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs
SBP <85 mmHg and change from BL <=-20 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
SBP >180 mmHg and change from BL >=20 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
DBP <50 mmHg and change from BL<=-15 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
DBP >110 mmHg and change from BL>=15 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Heart Rate <50 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Heart Rate >120 bpm
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Temperature <35.6 Degree C
|
1 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Temperature >37.7 Degree C
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Weight change from BL <=-7 %
|
4 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Weight change from BL >=7 %
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 99 (pre-dose)Population: Pharmacokinetic (PK) set included all participants from the safety set with at least 1 post dose PK sample collected.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=8 Participants
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=8 Participants
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Ctrough: Trough Serum Concentrations of Vedolizumab
|
40.2 ug/mL
Standard Deviation 37.2
|
12.3 ug/mL
Standard Deviation 5.49
|
Adverse Events
Vedolizumab 300 mg
Serious events: 6 serious events
Other events: 8 other events
Deaths: 4 deaths
Vedolizumab 600 mg
Serious events: 9 serious events
Other events: 9 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Vedolizumab 300 mg
n=8 participants at risk
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 participants at risk
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Thrombotic microangiopathy
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Febrile neutropenia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Lower gastrointestinal haemorrhage
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Rectal haemorrhage
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Upper gastrointestinal haemorrhage
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Death
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Acute graft versus host disease in liver
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Peritonitis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Bacterial sepsis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Citrobacter sepsis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Cytomegalovirus colitis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Enterococcal sepsis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Mediastinitis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pneumonia necrotising
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Urosepsis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 complication
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Cerebrovascular accident
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Swelling face
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Haematoma
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypotension
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 |
Vedolizumab 300 mg
n=8 participants at risk
Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
Vedolizumab 600 mg
n=9 participants at risk
Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
50.0%
4/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Neutropenia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Aplasia pure red cell
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Disseminated intravascular coagulation
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Cardiac disorders
Pericardial effusion
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Eye disorders
Vision blurred
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
37.5%
3/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Ascites
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Dry mouth
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Gingival pain
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Haemorrhoids
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Ileus paralytic
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Lower gastrointestinal haemorrhage
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Mouth ulceration
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Oral mucosa haematoma
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Proctalgia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Rectal haemorrhage
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Stomatitis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Tongue discolouration
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Oedema peripheral
|
37.5%
3/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pyrexia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Generalised oedema
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Asthenia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Catheter site haemorrhage
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Chills
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Injection site pain
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Oedema
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pain
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Graft versus host disease in skin
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Cytomegalovirus infection
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
BK virus infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Enterococcal infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Klebsiella infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Staphylococcal infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 enterococcal
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Aspergillus infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Clostridial infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Clostridium difficile infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Corona virus infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Cytomegalovirus colitis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Device related infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Enterobacter infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Mastoiditis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Otitis externa
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pneumonia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Presyncope
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pseudomonas infection
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Septic shock
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Sinusitis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Upper respiratory tract infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 bacterial
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Urosepsis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Vaginal infection
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Fall
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Laceration
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 bilirubin increased
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Gamma-glutamyltransferase increased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 decreased
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
White blood cell count decreased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Alanine aminotransferase increased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Aspartate aminotransferase increased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 alkaline phosphatase increased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 urea increased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
BK polyomavirus test positive
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 beta-D-glucan increased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 creatine increased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 pressure decreased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Cytomegalovirus test positive
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Electrocardiogram QT prolonged
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Liver function test abnormal
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Neutrophil count decreased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Oxygen saturation decreased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Urine output decreased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Vitamin D decreased
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Weight decreased
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypokalaemia
|
37.5%
3/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
55.6%
5/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hyperglycaemia
|
37.5%
3/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypoalbuminaemia
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypomagnesaemia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypocalcaemia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypermagnesaemia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Acidosis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Diabetes mellitus
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Electrolyte imbalance
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Fluid imbalance
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypernatraemia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypertriglyceridaemia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypoglycaemia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Malnutrition
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Muscular weakness
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pain in extremity
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Bone pain
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Myalgia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Dizziness
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
33.3%
3/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Headache
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Somnolence
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Ageusia
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Clonus
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Embolic stroke
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Head titubation
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Neuropathy peripheral
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Paraesthesia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Oedema genital
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Pain of skin
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Angioedema
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Blister
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Dry skin
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Erythema
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Ingrowing nail
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Lichen planus
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Onychoclasis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 macular
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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 maculo-papular
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Hypotension
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
22.2%
2/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Haematoma
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Jugular vein thrombosis
|
0.00%
0/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
11.1%
1/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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
Venoocclusive disease
|
12.5%
1/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
2/8 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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%
0/9 • From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 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