Trial Outcomes & Findings for Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (NCT NCT00619489)
NCT ID: NCT00619489
Last Updated: 2014-07-18
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities.
COMPLETED
PHASE2
72 participants
From Day 1 to Day 637
2014-07-18
Participant Flow
Participants took part in the study at 14 investigative sites in Canada and Russia, between 07 December 2007 and 31 March 2010.
Treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants were assigned to receive 6.0 mg/kg vedolizumab. Participants who rolled over from Study C13002 (NCT01177228) were assigned to receive 2.0 mg/kg vedolizumab.
Participant milestones
| Measure |
Vedolizumab 2 mg/kg
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
|
Overall Study
COMPLETED
|
14
|
1
|
|
Overall Study
NOT COMPLETED
|
23
|
34
|
Reasons for withdrawal
| Measure |
Vedolizumab 2 mg/kg
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
11
|
|
Overall Study
Rolled over to Study C13008 (NCT00790933
|
22
|
15
|
Baseline Characteristics
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Baseline characteristics by cohort
| Measure |
Vedolizumab 2 mg/kg
n=37 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 15.79 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Height
|
168.9 cm
STANDARD_DEVIATION 8.83 • n=5 Participants
|
168.4 cm
STANDARD_DEVIATION 11.49 • n=7 Participants
|
168.7 cm
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Weight
|
77.03 kg
STANDARD_DEVIATION 17.620 • n=5 Participants
|
70.81 kg
STANDARD_DEVIATION 17.820 • n=7 Participants
|
74.01 kg
STANDARD_DEVIATION 17.868 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.04 kg/m^2
STANDARD_DEVIATION 6.045 • n=5 Participants
|
24.86 kg/m^2
STANDARD_DEVIATION 5.286 • n=7 Participants
|
25.98 kg/m^2
STANDARD_DEVIATION 5.754 • n=5 Participants
|
|
Body Surface Area (BSA)
|
1.89 m^2
STANDARD_DEVIATION 0.233 • n=5 Participants
|
1.81 m^2
STANDARD_DEVIATION 0.270 • n=7 Participants
|
1.85 m^2
STANDARD_DEVIATION 0.253 • n=5 Participants
|
|
Inflammatory Bowel Disease Type
Crohn's Disease
|
0 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Inflammatory Bowel Disease Type
Ulcerative Colitis
|
37 participants
n=5 Participants
|
16 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 637Population: Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=37 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any Adverse Event
|
21 participants
|
35 participants
|
|
Number of Participants With Adverse Events (AEs)
Severe Adverse Event
|
2 participants
|
9 participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related Adverse Event
|
5 participants
|
21 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse Event Resulting in Discontinuation
|
0 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Event
|
3 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related Serious Adverse Event
|
1 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Event Resulting in Discontinuation
|
0 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
On-study Deaths
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: through Day 637Population: Safety analysis set
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=37 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Findings
ALT and AST Increased
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
Anemia
|
3 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
White Blood Cells Increased
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
White Blood Cells Decreased
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
C-reactive Protein Increased
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
Hypokalemia
|
0 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
Hypomagnesemia
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Laboratory Findings
Hepatic enzyme increased
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: through Day 637Population: Safety analysis set
At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=37 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.Population: Safety analysis set
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=37 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Number of Participants With Human Anti-human Antibodies (HAHA)
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 43, 99, 155 and 267, predosePopulation: The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by "n") are included.
Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=27 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=19 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Serum Concentration of Vedolizumab Before Dosing
Day 43 (n=27, 19)
|
25.2 μg/mL
Standard Deviation 6.68
|
76.2 μg/mL
Standard Deviation 36.9
|
|
Serum Concentration of Vedolizumab Before Dosing
Day 99 (n=24, 18)
|
11.2 μg/mL
Standard Deviation 4.33
|
32.5 μg/mL
Standard Deviation 20.5
|
|
Serum Concentration of Vedolizumab Before Dosing
Day 155 (n=26, 17)
|
8.40 μg/mL
Standard Deviation 3.65
|
26.4 μg/mL
Standard Deviation 17.7
|
|
Serum Concentration of Vedolizumab Before Dosing
Day 267 (n=26, 12)
|
7.40 μg/mL
Standard Deviation 3.18
|
25.2 μg/mL
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Days 43, 99, 155 and 267, predosePopulation: Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.
The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=26 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=20 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
Day 1 (0, 20)
|
NA % ACT1 binding
Standard Deviation NA
Data are not available because only treatment naïve participants were included at the Day 1 time point, and no naïve participants received 2 mg/kg.
|
14.6 % ACT1 binding
Standard Deviation 4.46
|
|
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
Day 43 (26, 19)
|
0.277 % ACT1 binding
Standard Deviation 0.216
|
0.311 % ACT1 binding
Standard Deviation 0.200
|
|
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
Day 99 (n=26, 17)
|
0.596 % ACT1 binding
Standard Deviation 0.690
|
0.288 % ACT1 binding
Standard Deviation 0.271
|
|
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
Day 155 (n=26, 17)
|
0.700 % ACT1 binding
Standard Deviation 1.50
|
1.09 % ACT1 binding
Standard Deviation 3.31
|
|
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
Day 267 (n=25, 12)
|
0.276 % ACT1 binding
Standard Deviation 0.247
|
0.767 % ACT1 binding
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Days 43, 99, 155 and 267, predosePopulation: Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.
The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.
Outcome measures
| Measure |
Vedolizumab 2 mg/kg
n=26 Participants
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=20 Participants
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
Day 1 (n=0, 20)
|
NA percent MADCAM binding
Standard Deviation NA
Data are not available because only treatment naïve participants were included at the Day 1 time point, and no naïve participants received 2 mg/kg.
|
18.5 percent MADCAM binding
Standard Deviation 5.95
|
|
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
Day 43 (n=26, 19)
|
0.538 percent MADCAM binding
Standard Deviation 0.512
|
0.705 percent MADCAM binding
Standard Deviation 1.29
|
|
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
Day 99 (n=26, 16)
|
1.22 percent MADCAM binding
Standard Deviation 1.20
|
0.838 percent MADCAM binding
Standard Deviation 0.950
|
|
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
Day 155 (n=26, 16)
|
0.646 percent MADCAM binding
Standard Deviation 0.673
|
0.369 percent MADCAM binding
Standard Deviation 0.540
|
|
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
Day 267 (n=25, 12)
|
1.05 percent MADCAM binding
Standard Deviation 1.38
|
0.975 percent MADCAM binding
Standard Deviation 1.55
|
Adverse Events
Vedolizumab 2 mg/kg
Vedolizumab 6 mg/kg
Serious adverse events
| Measure |
Vedolizumab 2 mg/kg
n=37 participants at risk
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 participants at risk
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Infections and infestations
Furuncle
|
2.7%
1/37 • From Day 1 to Day 637
|
0.00%
0/35 • From Day 1 to Day 637
|
|
Infections and infestations
Viral infection
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.7%
1/37 • From Day 1 to Day 637
|
0.00%
0/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Eye disorders
Vision blurred
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
General disorders
Infusion-related reaction
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/37 • From Day 1 to Day 637
|
2.9%
1/35 • From Day 1 to Day 637
|
|
Reproductive system and breast disorders
Uterine polyp
|
2.7%
1/37 • From Day 1 to Day 637
|
0.00%
0/35 • From Day 1 to Day 637
|
Other adverse events
| Measure |
Vedolizumab 2 mg/kg
n=37 participants at risk
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
Vedolizumab 6 mg/kg
n=35 participants at risk
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.5%
5/37 • From Day 1 to Day 637
|
20.0%
7/35 • From Day 1 to Day 637
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • From Day 1 to Day 637
|
8.6%
3/35 • From Day 1 to Day 637
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
1/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Infections and infestations
Respiratory tract infection viral
|
5.4%
2/37 • From Day 1 to Day 637
|
0.00%
0/35 • From Day 1 to Day 637
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Infections and infestations
Viral infection
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • From Day 1 to Day 637
|
20.0%
7/35 • From Day 1 to Day 637
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.4%
2/37 • From Day 1 to Day 637
|
0.00%
0/35 • From Day 1 to Day 637
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/37 • From Day 1 to Day 637
|
8.6%
3/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • From Day 1 to Day 637
|
8.6%
3/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • From Day 1 to Day 637
|
8.6%
3/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • From Day 1 to Day 637
|
8.6%
3/35 • From Day 1 to Day 637
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • From Day 1 to Day 637
|
14.3%
5/35 • From Day 1 to Day 637
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
General disorders
Influenza like illness
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
|
Psychiatric disorders
Depression
|
0.00%
0/37 • From Day 1 to Day 637
|
5.7%
2/35 • From Day 1 to Day 637
|
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