Trial Outcomes & Findings for Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies (NCT NCT01924689)
NCT ID: NCT01924689
Last Updated: 2019-09-09
Results Overview
To determine the safety profile of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection. CTCAE: Common Terminology Criteria for Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
From screening until follow-up visit (up to 12 months)
Results posted on
2019-09-09
Participant Flow
This study was conducted at 7 study centers in the United States. A total of 24 patients were enrolled at 4 study centers. Three study centers did not enroll patients.
Patients who provided informed consent underwent screening procedures within the 21 days preceding C. novyi-NT (Clostridium novyi-Non-Toxic) spore administration. Patients reported to the clinical site 24 hours prior to study Day 0 to reconfirm eligibility and for baseline assessments. Assessments were done as per the schedule of assessment.
Participant milestones
| Measure |
Cohort 1
Patients received only single dose of C. novyi-NT spores (Cohort 1: 1 x 10\^4 spores) as an intratumoral (IT) injection, per protocol (pp).
|
Cohort 2
Patients received only single dose of C. novyi-NT spores (Cohort 2: 3 x 10\^4 spores) as an IT injection, pp.
|
Cohort 3
Patients received only single dose of C. novyi-NT spores (Cohort 3: 10 x 10\^4 spores) as an IT injection, pp.
|
Cohort 4
Patients received only single dose of C. novyi-NT spores (Cohort 4: 30 x 10\^4 spores) as an IT injection, pp.
|
Cohort 5
Patients received only single dose of C. novyi-NT spores (Cohort 5: 100 x 10\^4 spores) as an IT injection, pp.
|
Cohort 6
Patients received only single dose of C. novyi-NT spores (Cohort 6: 300 x 10\^4 spores) as an IT injection, pp.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
6
|
6
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
6
|
6
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
Patients received only single dose of C. novyi-NT spores (Cohort 1: 1 x 10\^4 spores) as an intratumoral (IT) injection, per protocol (pp).
|
Cohort 2
Patients received only single dose of C. novyi-NT spores (Cohort 2: 3 x 10\^4 spores) as an IT injection, pp.
|
Cohort 3
Patients received only single dose of C. novyi-NT spores (Cohort 3: 10 x 10\^4 spores) as an IT injection, pp.
|
Cohort 4
Patients received only single dose of C. novyi-NT spores (Cohort 4: 30 x 10\^4 spores) as an IT injection, pp.
|
Cohort 5
Patients received only single dose of C. novyi-NT spores (Cohort 5: 100 x 10\^4 spores) as an IT injection, pp.
|
Cohort 6
Patients received only single dose of C. novyi-NT spores (Cohort 6: 300 x 10\^4 spores) as an IT injection, pp.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease progression
|
0
|
0
|
2
|
0
|
3
|
2
|
|
Overall Study
New therapy or study
|
3
|
2
|
1
|
4
|
2
|
0
|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 14.13 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 12.72 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 9.85 • n=21 Participants
|
65.0 years
STANDARD_DEVIATION 0 • n=10 Participants
|
56.0 years
STANDARD_DEVIATION 11.32 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From screening until follow-up visit (up to 12 months)Population: The safety data set included all patients who received any amount of C. novyi-NT, the investigational medicinal product (IMP). Patients were included in the safety analysis according to the dose of IMP received.
To determine the safety profile of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection. CTCAE: Common Terminology Criteria for Adverse Events
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Serious TEAEs
|
1 Patients
|
2 Patients
|
1 Patients
|
4 Patients
|
3 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
All TEAEs
|
3 Patients
|
3 Patients
|
4 Patients
|
6 Patients
|
6 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Related TEAEs
|
2 Patients
|
3 Patients
|
2 Patients
|
4 Patients
|
3 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
CTCAE Grade 1 TEAEs
|
3 Patients
|
3 Patients
|
4 Patients
|
5 Patients
|
6 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
CTCAE Grade 2 TEAEs
|
1 Patients
|
3 Patients
|
4 Patients
|
3 Patients
|
2 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
CTCAE Grade 3 TEAEs
|
1 Patients
|
3 Patients
|
2 Patients
|
3 Patients
|
3 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Life-Threatening TEAEs
|
0 Patients
|
1 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
2 Patients
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Deaths
|
0 Patients
|
1 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
PRIMARY outcome
Timeframe: From screening until follow-up visit (up to 12 months)Population: The safety data set included all patients who received any amount of C. novyi-NT, IMP. Patients were included in the safety analysis according to the dose of IMP received.
To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
Patient with any AEs qualified as DLTs
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
2 Patients
|
|
Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
Patient with Gas gangrene qualified as DLTs
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
|
Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
Patient with Sepsis qualified as DLTs
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
1 Patients
|
SECONDARY outcome
Timeframe: At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing)Population: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1. Change from baseline is presented.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 1, Month 1
|
1.32 Percentage of change
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 1, Month 2
|
-23.68 Percentage of change
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 2, Month 1 and Month 2
|
0 Percentage of change
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 3, Month 1
|
19.23 Percentage of change
|
—
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 4, Month 1
|
—
|
-21.90 Percentage of change
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 4, Month 2
|
—
|
0 Percentage of change
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 5, Month 1
|
—
|
11.54 Percentage of change
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 6, Month 1
|
—
|
10.71 Percentage of change
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 6, Month 2
|
—
|
32.14 Percentage of change
|
—
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 7, Month 1
|
—
|
—
|
NA Percentage of change
This patient did not have tumor assessments performed at Month 1
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 8, Month 1
|
—
|
—
|
-20 Percentage of change
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 9, Month 1
|
—
|
—
|
-1.85 Percentage of change
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 10, Month 1
|
—
|
—
|
6.67 Percentage of change
|
—
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 11, Month 1
|
—
|
—
|
—
|
-2.22 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 11, Month 2
|
—
|
—
|
—
|
15.56 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 12, Month 1
|
—
|
—
|
—
|
13.56 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 12, Month 2
|
—
|
—
|
—
|
1.69 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 12, Month 4
|
—
|
—
|
—
|
-13.56 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 12, Month 8
|
—
|
—
|
—
|
13.56 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 13, Month 1
|
—
|
—
|
—
|
26.61 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 13, Month 2
|
—
|
—
|
—
|
42.20 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 14, Month 1
|
—
|
—
|
—
|
14.29 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 14, Month 2
|
—
|
—
|
—
|
14.29 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 15, Month 1
|
—
|
—
|
—
|
16.95 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 16, Month 1
|
—
|
—
|
—
|
-11.76 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 16, Month 2
|
—
|
—
|
—
|
-14.29 Percentage of change
|
—
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 17, Month 1
|
—
|
—
|
—
|
—
|
-7.14 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 17, Month 2
|
—
|
—
|
—
|
—
|
0 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 17, Month 4
|
—
|
—
|
—
|
—
|
3.57 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 17, Month 8
|
—
|
—
|
—
|
—
|
10.71 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 18, Month 1
|
—
|
—
|
—
|
—
|
30.23 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 18, Month 2
|
—
|
—
|
—
|
—
|
86.05 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 19, Month 1
|
—
|
—
|
—
|
—
|
-6.67 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 19, Month 2
|
—
|
—
|
—
|
—
|
6.67 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 20, Month 1
|
—
|
—
|
—
|
—
|
—
|
48.24 Percentage of change
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 20, Month 2
|
—
|
—
|
—
|
—
|
—
|
23.53 Percentage of change
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 21, Month 1, Month 2, Month 4
|
—
|
—
|
—
|
—
|
—
|
NA Percentage of change
This patient did not have tumor assessments performed at Month 1
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 22, Month 1
|
—
|
—
|
—
|
—
|
12.20 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 22, Month 2
|
—
|
—
|
—
|
—
|
19.51 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 23, Month 1
|
—
|
—
|
—
|
—
|
3.13 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 23, Month 2
|
—
|
—
|
—
|
—
|
18.75 Percentage of change
|
—
|
|
Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Patient 24, Month 1
|
—
|
—
|
—
|
—
|
19.30 Percentage of change
|
—
|
SECONDARY outcome
Timeframe: At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)Population: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included a response for the injected lesion. Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 2, Progressive Disease
|
0 Patients
|
2 Patients
|
0 Patients
|
1 Patients
|
2 Patients
|
1 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 2, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 4, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 4, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 4, Stable Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 4, Progressive Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 4, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 8, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 8, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 8, Stable Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 8, Progressive Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 8, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 1, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 1, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 1, Stable Disease
|
3 Patients
|
3 Patients
|
3 Patients
|
6 Patients
|
6 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 1, Progressive Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 1, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 2, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 2, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With RECIST Assessment on the Injected Lesion
Month 2, Stable Disease
|
2 Patients
|
0 Patients
|
0 Patients
|
4 Patients
|
3 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)Population: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
To document preliminary anti-tumor activity of an overall response after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included an overall response.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Overall RECIST Response
Month 1, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 1, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 1, Stable Disease
|
2 Patients
|
2 Patients
|
3 Patients
|
6 Patients
|
6 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 1, Progressive Disease
|
1 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 1, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
|
Number of Patients With Overall RECIST Response
Month 2, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 2, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 2, Stable Disease
|
2 Patients
|
0 Patients
|
0 Patients
|
4 Patients
|
3 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 2, Progressive Disease
|
0 Patients
|
2 Patients
|
0 Patients
|
1 Patients
|
2 Patients
|
1 Patients
|
|
Number of Patients With Overall RECIST Response
Month 2, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 4, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 4, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 4, Stable Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 4, Progressive Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 4, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 8, Complete Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 8, Partial Response
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 8, Stable Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 8, Progressive Disease
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
|
Number of Patients With Overall RECIST Response
Month 8, Unknown
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: At Screening, at Days -1 to 0, at Days 1, 2, 3, 4, 5, 7, at follow up (at 2 months (±2 days) after dosing)Population: The safety data set included all patients who received any amount of C. novyi-NT, the IMP. Patients were included in the safety analysis according to the dose of IMP received. Note: Two patients had positive C.novyi culture at Screening due to contamination, and one patient in Cohort 4 had positive C. novyi culture on Day 3 due to contamination.
To study the presence of circulating C. novyi-NT spores after administration as a single IT injection to humans with treatment-refractory solid tumor malignancies.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 3
|
1 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 4
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 5
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 7
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Month 2
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Screening
|
0 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day -1 to Day 0
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 1
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
1 Patients
|
|
Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Scheduled, Day 2
|
0 Patients
|
0 Patients
|
0 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. The following table presents the data for the patients who had analyzable cytokine data. This table was included to simply indicate the number of patients who participated in the cytokine response analysis.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 Participants
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 Participants
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Cytokine Responses Analyzed
|
3 Patients
|
3 Patients
|
4 Patients
|
6 Patients
|
6 Patients
|
2 Patients
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Release of T-cell cytokines and effector molecules (interferon \[IFN\]-γ , Granzyme B, and tumor necrosis factor \[TNF\]-α) from the patient's own peripheral blood mononuclear cells (PBMCs) treated with allogenic tumor cell line lysates were quantified by Enzyme-Linked Immunosorbent Spot (ELISPOT) assays. A positive response was defined as a frequency that is significantly (p \<0.05, two-tailed t-test) greater than the mean of control no-antigen wells and detectable (i.e., \>1:100,000). No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=4 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=1 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Systemic Tumor Antigen Specific T-cell Responses
|
1 Patients
|
2 Patients
|
3 Patients
|
1 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Immunostaining for tumor infiltrating cells was analyzed independently by 2 investigators. Respective counting of 3 slides per patient between 5 to 20 fields of vision at 200x were scored using the modified ALLRED scoring method. Respective counts were averaged in each case. Pre and post treatment needle biopsies from injected and non-injected tumors were stained for the presence of tumor infiltrating immune cells. No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 Participants
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=3 Participants
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=2 Participants
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Number of Patients With Local Tumor-specific T-cell Responses
|
0 Patients
|
1 Patients
|
0 Patients
|
2 Patients
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 6
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 participants at risk
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 participants at risk
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 participants at risk
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 participants at risk
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 participants at risk
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Disease progression
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
2/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Gastrointestinal disorders
Oedema peripheral
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Reproductive system and breast disorders
Genital swelling
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Surgical and medical procedures
Limb salvage therapy
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Surgical and medical procedures
Osteosynthesis
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Cohort 1: 1 x 10\^4 spores
|
Cohort 2
n=3 participants at risk
Cohort 2: 3 x 10\^4 spores
|
Cohort 3
n=4 participants at risk
Cohort 3: 10 x 10\^4 spores
|
Cohort 4
n=6 participants at risk
Cohort 4: 30 x 10\^4 spores
|
Cohort 5
n=6 participants at risk
Cohort 5: 100 x 10\^4 spores
|
Cohort 6
n=2 participants at risk
Cohort 6: 300 x 10\^4 spores
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
100.0%
3/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
75.0%
3/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
2/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
2/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
100.0%
2/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
100.0%
4/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
66.7%
2/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
66.7%
2/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
100.0%
4/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
75.0%
3/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
66.7%
2/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
3/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
3/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
66.7%
2/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
2/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
2/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
16.7%
1/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
1/3 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
25.0%
1/4 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
33.3%
2/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
0.00%
0/6 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
50.0%
1/2 • From screening until follow-up visit (up to 12 months)
An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains confidential information of BioMed Valley Discoveries, Inc. Do not copy or distribute without written permission from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER