Trial Outcomes & Findings for T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma (NCT NCT03958656)
NCT ID: NCT03958656
Last Updated: 2021-09-09
Results Overview
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
Results posted on
2021-09-09
Participant Flow
3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
Participant milestones
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Overall Study
Received anti-myeloma prescription (Rx)
|
0
|
1
|
0
|
0
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Started anti-cancer treatment
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Each row represents one participant.
Baseline characteristics by cohort
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 Participants
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=4 Participants
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=5 Participants
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 Participants
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
12 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=13 Participants
|
|
Age, Continuous
|
56.33 years
STANDARD_DEVIATION 5.42 • n=3 Participants
|
50.05 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
53.61 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 0 • n=1 Participants
|
54.83 years
STANDARD_DEVIATION 8.07 • n=13 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
7 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
13 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
8 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
5 participants
n=5 Participants
|
1 participants
n=1 Participants
|
13 participants
n=13 Participants
|
|
Number of Prior Lines of Therapy
Participant 1
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
—
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 2
|
4 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
—
|
4 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 3
|
3 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
—
|
3 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 4
|
—
|
7 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
7 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 5
|
—
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 6
|
—
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
—
|
6 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 7
|
—
|
—
|
4 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
4 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 8
|
—
|
—
|
8 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
8 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 9
|
—
|
—
|
5 prior therapy
n=1 Participants • Each row represents one participant.
|
—
|
5 prior therapy
n=1 Participants • Each row represents one participant.
|
|
Number of Prior Lines of Therapy
Participant 10
|
—
|
—
|
—
|
5 prior therapy
n=1 Participants • Each row represents one participant.
|
5 prior therapy
n=1 Participants • Each row represents one participant.
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.Population: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.
Outcome measures
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 Participants
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=3 Participants
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=3 Participants
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 Participants
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
< Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
Grade 2
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
Grade 3
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
Grade 4
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.Population: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 Participants
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=3 Participants
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=3 Participants
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 Participants
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At two and five weeks for stable disease and partial remission, respectively, and up to 5 months and 23 days for progressive diseasePopulation: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated. No weeks are necessary for PD.
Response was assessed by the International Uniform Response Criteria for Multiple myeloma 2016 updated version. Complete Remission (CR) is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200mg per 24 h). Progressive Disease (PD) is serum M-component (minimum absolute increase of 0.5g/dL), or urine M-component (minimum absolute increase of 200mg/24h). Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or progressive disease.
Outcome measures
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 Participants
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=3 Participants
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=3 Participants
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 Participants
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Number of Participants With a Response
Partial Remission at 5 Weeks
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response
Stable Disease at 2 Weeks
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With a Response
Progressive Disease
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LEVEL 2 - 2.0x10^6 Per kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
LEVEL 3 - 6.0x10^6 Per kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
LEVEL 4 - 12.0x10^6 Per kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 participants at risk
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=3 participants at risk
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=3 participants at risk
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 participants at risk
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
Other adverse events
| Measure |
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
n=3 participants at risk
0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 2 - 2.0x10^6 Per kg
n=3 participants at risk
2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 3 - 6.0x10^6 Per kg
n=3 participants at risk
6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
LEVEL 4 - 12.0x10^6 Per kg
n=1 participants at risk
12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
CPK increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
General disorders
Chills
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Infections and infestations
Infections and infestations - Other, staph. Epidermidis
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Actinic keratosis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 12 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 24 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 14 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
|
100.0%
1/1 • Number of events 16 • Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place