Trial Outcomes & Findings for Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas (NCT NCT01445535)
NCT ID: NCT01445535
Last Updated: 2021-11-03
Results Overview
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). 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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
Results posted on
2021-11-03
Participant Flow
Participant milestones
| Measure |
Cohort 1 - 3.4 mg/kg
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1 - 3.4 mg/kg
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Overall Study
Enrolled/taken off study, no drug avail.
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
1
|
0
|
1
|
0
|
|
Overall Study
PI discretion
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
Cohort 1 - 3.4 mg/kg
n=3 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 Participants
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 Participants
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 Participants
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Age, Continuous
|
37.43 years
STANDARD_DEVIATION 16.1 • n=93 Participants
|
42.2 years
STANDARD_DEVIATION 10.31 • n=4 Participants
|
70.03 years
STANDARD_DEVIATION 6.87 • n=27 Participants
|
45.38 years
STANDARD_DEVIATION 17.1 • n=483 Participants
|
48.76 years
STANDARD_DEVIATION 12.59 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
6 participants
n=483 Participants
|
15 participants
n=36 Participants
|
|
Disease Status
ATL
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Disease Status
PTCL, NOS
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Disease Status
EATL
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Disease Status
CGDTCL
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). 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 |
Cohort 1 - 3.4 mg/kg
n=3 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 Participants
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 Participants
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 Participants
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: First 30 days after treatment initiation.A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs.
Outcome measures
| Measure |
Cohort 1 - 3.4 mg/kg
n=15 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Siplizumab
|
15 mg/kg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD.
Outcome measures
| Measure |
Cohort 1 - 3.4 mg/kg
n=3 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 Participants
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 Participants
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 Participants
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Number of Participants With a Response to Therapy
Complete Remission
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With a Response to Therapy
Complete Response Unconfirmed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Partial Response
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Relapsed Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Progressive Disease
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: On-study date until date of progression or last follow up, approximately 7 months.Population: Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol.
Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort 1 - 3.4 mg/kg
n=15 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Overall Progression Free Survival (PFS)
|
6.8 Months
Interval 2.9 to 27.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study date until date of death or last follow up, approximately 12 months.Population: Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol.
Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort 1 - 3.4 mg/kg
n=15 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
12.1 Months
Interval 6.7 to 30.7
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First 30 days after treatment initiation.DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs.
Outcome measures
| Measure |
Cohort 1 - 3.4 mg/kg
n=3 Participants
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 Participants
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 Participants
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 Participants
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Number of Dose-Limiting Toxicities (DLT)
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
Adverse Events
Cohort 1 - 3.4 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2 - 4.8 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3 - 8.5 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 4 - 15 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1 - 3.4 mg/kg
n=3 participants at risk
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 participants at risk
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 participants at risk
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 participants at risk
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
Other adverse events
| Measure |
Cohort 1 - 3.4 mg/kg
n=3 participants at risk
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 2 - 4.8 mg/kg
n=3 participants at risk
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 3 - 8.5 mg/kg
n=3 participants at risk
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
Cohort 4 - 15 mg/kg
n=6 participants at risk
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urethra
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Supraventricular tachycardia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 5 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 5 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
4/6 • Number of events 9 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
100.0%
3/3 • Number of events 11 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 18 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 12 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 20 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
3/3 • Number of events 14 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 20 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 12 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 23 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 16 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 15 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 22 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Mood alteration::Anxiety
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
4/6 • Number of events 6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Neuropathy: motor
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Neuropathy: sensory
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
4/6 • Number of events 5 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
3/3 • Number of events 13 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 14 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 20 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
4/6 • Number of events 6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest/thorax NOS
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Pain::Head/headache
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
4/6 • Number of events 7 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain::Skin
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
3/3 • Number of events 11 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 15 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
83.3%
5/6 • Number of events 15 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
50.0%
3/6 • Number of events 6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Rigors/chills
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Sweating (diaphoresis)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
CD4 count
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Pain::Lymph node
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Ear and labyrinth disorders
Pain::Middle ear
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/6 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
100.0%
3/3 • Number of events 9 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Confusion
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Eye disorders
Pain::Eye
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation::Chemoradiation
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
|
General disorders
Weight loss
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
0.00%
0/3 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place