Trial Outcomes & Findings for CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (NCT NCT03774654)
NCT ID: NCT03774654
Last Updated: 2026-07-13
Results Overview
DLT rate is defined as the proportion of subjects with DLT evaluated as per the NCI CTCAE v5.0 with the exception of CRS and neurological toxicities that are related to T-cell infusions. GVHD will be graded according to the BMT CTN Technical Manual of Procedures v3.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
4 weeks post T cell infusion
Results posted on
2026-07-13
Participant Flow
Participant milestones
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Dose Level 1
STARTED
|
3
|
0
|
0
|
3
|
|
Dose Level 1
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 1
NOT COMPLETED
|
3
|
0
|
0
|
3
|
|
Dose Level 2
STARTED
|
0
|
4
|
0
|
0
|
|
Dose Level 2
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 2
NOT COMPLETED
|
0
|
4
|
0
|
0
|
|
Dose Level 3
STARTED
|
0
|
0
|
3
|
0
|
|
Dose Level 3
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 3
NOT COMPLETED
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Dose Level 1
Death
|
2
|
0
|
0
|
2
|
|
Dose Level 1
On long-term follow-up
|
1
|
0
|
0
|
1
|
|
Dose Level 2
Death
|
0
|
4
|
0
|
0
|
|
Dose Level 3
On long-term follow-up
|
0
|
0
|
2
|
0
|
|
Dose Level 3
PI approved off-study
|
0
|
0
|
1
|
0
|
Baseline Characteristics
CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)
Baseline characteristics by cohort
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
n=4 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
n=3 Participants
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=20 Participants
|
57.5 years
n=20 Participants
|
39.0 years
n=40 Participants
|
48.0 years
n=5 Participants
|
57.0 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post T cell infusionPopulation: The analysis population includes participants who received a CD19.CAR-aNKT cell infusion cells and were evaluable for dose limiting toxicity (DLT), defined as those who developed DLTs or completed the 4-week DLT evaluation period after the T cell infusion.
DLT rate is defined as the proportion of subjects with DLT evaluated as per the NCI CTCAE v5.0 with the exception of CRS and neurological toxicities that are related to T-cell infusions. GVHD will be graded according to the BMT CTN Technical Manual of Procedures v3.0.
Outcome measures
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
n=4 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
n=3 Participants
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) Rate
|
0.0000 proportion of participants
Interval 0.0 to 0.7076
|
0.0000 proportion of participants
Interval 0.0 to 0.6024
|
0.0000 proportion of participants
Interval 0.0 to 0.7076
|
0.0000 proportion of participants
Interval 0.0 to 0.7076
|
SECONDARY outcome
Timeframe: Up to 6 months after infusionPopulation: The analysis population includes participants who received 15.GPC3-CAR T cells and had available response data.
Overall response rate is defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) according to the Lugano criteria for non-Hodgkin lymphomas (for NHL) and the IWG (for CLL), or the proportion of patients with morphologic CR (for ALL).
Outcome measures
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
n=4 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
n=3 Participants
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
n=3 Participants
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Overall Response Rate According to the Lugano Criteria for Non-Hodgkin Lymphomas (for NHL) and the IWG (for CLL), or the Proportion of Patients With Morphologic CR (for ALL).
|
0.6667 proportion of participants
Interval 0.0943 to 0.9916
|
0.2500 proportion of participants
Interval 0.0063 to 0.8059
|
0.3333 proportion of participants
Interval 0.0084 to 0.9057
|
0.3333 proportion of participants
Interval 0.0084 to 0.9057
|
Adverse Events
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
n=3 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
n=4 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
n=3 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
n=3 participants at risk
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Nervous system disorders
Nervous system disorders - Other, specify : ICAN
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
Other adverse events
| Measure |
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 1
n=3 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 2
n=4 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 2(3 x 10\^7/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort A, Non-ALL) - Dose Level 3
n=3 participants at risk
Participants without refractory/relapsed B-cell NHL or leukemia (non-ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 3(1 x 10\^8/m2) after lymphodepletion chemotherapy.
|
CD19.CAR-aNKT Cells (Cohort B, ALL) - Dose Level 1
n=3 participants at risk
Participants with refractory/relapsed B-cell NHL or leukemia (ALL) received a CD19.CAR-aNKT cell infusion at Dose Level 1(1 x 10\^7/m2) after lymphodepletion chemotherapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify : White blood cell decreased
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
50.0%
2/4 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Chills
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Fatigue
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
50.0%
2/4 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Fever
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Infusion site extravasation
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Localized edema
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Blood bicarbonate decreased
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
4/4 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
75.0%
3/4 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
4/4 • Number of events 5 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
4/4 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
100.0%
3/3 • Number of events 4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
50.0%
2/4 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
66.7%
2/3 • Number of events 2 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
25.0%
1/4 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/4 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
33.3%
1/3 • Number of events 1 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
0.00%
0/3 • Data on all adverse experiences/toxicities regardless of seriousness were collected for 4 weeks after the last dosing of the study product. Adverse events were monitored/assessed through 4 weeks after the last dose of the study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place