Trial Outcomes & Findings for Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia (NCT NCT02879695)
NCT ID: NCT02879695
Last Updated: 2026-05-29
Results Overview
Defined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Up to 5.5 years
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Dose Level A1
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
Dose Level B1
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
11
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Dose Level A1
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
Dose Level B1
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
Did not start study treatment
|
2
|
0
|
3
|
0
|
Baseline Characteristics
Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Dose Level A1
n=8 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=11 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 Years
n=51 Participants
|
57 Years
n=14 Participants
|
54 Years
n=65 Participants
|
45 Years
n=57 Participants
|
55 Years
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
2 Participants
n=57 Participants
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
4 Participants
n=57 Participants
|
14 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
9 Participants
n=65 Participants
|
5 Participants
n=57 Participants
|
25 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
8 Participants
n=65 Participants
|
3 Participants
n=57 Participants
|
22 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
2 Participants
n=57 Participants
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=51 Participants
|
3 participants
n=14 Participants
|
11 participants
n=65 Participants
|
6 participants
n=57 Participants
|
28 participants
n=39 Participants
|
|
Height
|
171.3 centimeter (cm)
n=51 Participants
|
177.8 centimeter (cm)
n=14 Participants
|
167.6 centimeter (cm)
n=65 Participants
|
162.7 centimeter (cm)
n=57 Participants
|
169.5 centimeter (cm)
n=39 Participants
|
|
Weight
|
85.5 kilogram (kg)
n=51 Participants
|
96.5 kilogram (kg)
n=14 Participants
|
75.3 kilogram (kg)
n=65 Participants
|
73.4 kilogram (kg)
n=57 Participants
|
83.7 kilogram (kg)
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 5.5 yearsPopulation: All participants who started treatment.
Defined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported.
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=11 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=8 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events
Grades 1-2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events
Grade 5
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events
Grade 4
|
2 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events
Grade 3
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 5.5 yearsPopulation: Only participants who started Nivolumab, with or without Ipilimumab, were analyzed.
Maximum tolerated dose was determined by the absence of dose limiting toxicity in each patient assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Dose Limiting Toxicities were evaluated during treatment; therefore, the time frame is from the first participant starting treatment to the last participant completing treatment.
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=8 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
Experienced a Dose Limiting Toxicity
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Dose Limiting Toxicities
Did not experience a Dose Limiting Toxicity
|
1 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5.5 yearsPopulation: Only participants with a clinical response (i.e. achieving remission) were analyzed.
Will be assessed by flow cytometry. Participants who have a clinical response (responders) were evaluated for minimal residual disease negative versus minimal residual disease positive. These are the participants with remission as provided in the Secondary Outcome #4.
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=5 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=4 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=5 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Count of Participants Responders With Minimal Residual Disease
Negative MRD
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Count of Participants Responders With Minimal Residual Disease
Positive MRD
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5.5 yearsPopulation: All participants who started treatment were analyzed.
Remission includes participants achieving complete remission or complete remission with incomplete blood count recovery by standard leukemia outcome measures.
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=11 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=8 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants Achieving Remission
Achieved remission
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Achieving Remission
Did not achieve remission
|
0 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 5.5 yearsPopulation: Only responders were included in the analysis.
Will be analyzed using the Kaplan Meier method. A sensitivity analysis may be performed to evaluate duration of response while excluding patients who go on to have an allogeneic-hematopoietic stem cell transplantation. Time from measured response to progressive disease, death, or study end, assessed up to 2 years after treatment
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=5 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=4 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=5 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Duration of Response
|
51 Days
Interval 44.0 to 828.0
|
695 Days
Interval 54.0 to 849.0
|
490 Days
Interval 155.0 to 996.0
|
205 Days
Interval 116.0 to 844.0
|
SECONDARY outcome
Timeframe: Up to 5.5 yearsPopulation: Only participants who started nivolumab, with or without ipilimumab, were analyzed.
Determined from the first day of treatment on the study until death or last known follow up, assessed up to 2 years after completing treatment.
Outcome measures
| Measure |
Dose Level B1
n=3 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Level B-1
n=8 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=6 Participants
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
|---|---|---|---|---|
|
Overall Survival
|
182 Days
Interval 86.0 to 864.0
|
552 Days
Interval 22.0 to 910.0
|
381 Days
Interval 85.0 to 857.0
|
462 Days
Interval 92.0 to 876.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearTo examine changes in absolute lymphocyte count before and after blinatumomab and immune checkpoint inhibitor(s) therapy in both peripheral blood and the bone marrow microenvironment. Timeframe is based on duration of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearWill be assessed by flow cytometry. The analyses of pre- and post-treatment peripheral blood and bone marrow specimens for immune parameters will be descriptive and graphical in nature. Data will be summarized for each patient group separately. Flow values at each time point will be summarized using geometric means and standard deviation. Differences in baseline values between patient subgroups will be explored using linear regression models. Timeframe based on duration of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearTo explore changes in T cell co-signaling receptors expression in defined T cell subpopulations and their canonic transcription factor expression in both peripheral blood and bone marrow before and post-blinatumomab, and immune checkpoint inhibitor(s) therapy. Time frame based on duration of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearTo examine changes in expression of co-signaling molecules on leukemia blasts (CD10+/CD19+/CD34+) before and after treatment with blinatumomab and checkpoint inhibitors. Time frame based on the duration of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearTo examine the serum levels of cytokines before and after treatment with blinatumomab and checkpoint inhibitors, including the levels of sCTLA-4. Time frame based on duration of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: About 1 yearTo perform immune profiling of T cell repertoire and characterize T cell transcriptional signature before and after treatment. Time frame based on duration of treatment.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level B-1
Serious events: 7 serious events
Other events: 10 other events
Deaths: 5 deaths
Dose Expansion (Dose Level A1)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level A1
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Dose Level B1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level B-1
n=11 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=8 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
Dose Level B1
n=3 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
9.1%
1/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Disease Progression
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Non Cardiac Chest Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Immune system disorders
GVHD
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Transient Ischemic Attacks
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Cerebellar Syndrome
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
Other adverse events
| Measure |
Dose Level B-1
n=11 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
Dose Expansion (Dose Level A1)
n=6 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 80 mg IV every 2 weeks.
|
Dose Level A1
n=8 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks.
|
Dose Level B1
n=3 participants at risk
Blinatumomab continuous IV Days 1-28 with Nivolumab 240 mg IV every 2 weeks and Ipilimumab 1 mg/kg IV every 6 weeks.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Hepatotoxicity
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Perianal Lesions
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Postoperative Hemorrhage
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Tracheal Hemorrhage
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Pulmonary Nodules
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Rigors
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Immune system disorders
Cytokine Release Syndrome
|
18.2%
2/11 • Approximately 6.5 years.
|
66.7%
4/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Immune system disorders
Hypoimmunoglobulinemia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Bone Infection
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Catheter Infection
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
COVID SARS 2
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Enterocolitis Infectious
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Lung Infection
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
PICC Site Infection
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Infections and infestations
Skin Infection
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Infections and infestations
Viremia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone Infection
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
27.3%
3/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
54.5%
6/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Investigations
Alkaline Phosphatase Increased
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
54.5%
6/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Blood Bilirubin Increased
|
54.5%
6/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
62.5%
5/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Creatinine Increased
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
D-Dimer Increase
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Fibrinogen Decreased
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Generalized Edema
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
GGT Increased
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Hyperphosphatemia
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Immunoglobulins Decreased
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
INR Increased
|
54.5%
6/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
LDH Increased
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Lipase Increased
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Lymphocyte Count Decreased
|
81.8%
9/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Investigations
Neutrophil Count Decreased
|
45.5%
5/11 • Approximately 6.5 years.
|
50.0%
3/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Investigations
Platelet Count Decreased
|
72.7%
8/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
62.5%
5/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Investigations
PT Prolonged
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Serum Amylase Increased
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Weight Gain
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Investigations
Weight Loss
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Investigations
White Blood Cell Decreased
|
72.7%
8/11 • Approximately 6.5 years.
|
50.0%
3/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Investigations
White Blood Cell Increased
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
4/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Blood Bicarbonate Decrease
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
54.5%
6/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
36.4%
4/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.4%
4/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.3%
3/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Thiamine Deficiency
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Metabolism and nutrition disorders
Zinc Deficiency
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Paresthesia
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Sinus Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Psychiatric disorders
Delirium
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Renal and urinary disorders
Hematuria
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Renal and urinary disorders
Penile Bleeding
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Renal and urinary disorders
Urinary Retention
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Reproductive system and breast disorders
Genital Edema
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
3/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema RLE
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
36.4%
4/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Surgical and medical procedures
Excision Of Presumptive Osteomyelitis
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Surgical and medical procedures
Foot Incision And Debridement
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Hypertension
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Vascular disorders
Hypotension
|
27.3%
3/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Non-occlusive Thrombus
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
PICC Site Irritation
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Progression Of Disease
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Lymphocyte Count Increase
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
PT Increased
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Sinus Bradycardia
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Cardiac disorders
Sinus Trachycardia
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Endocrine disorders
Adrenal Insufficiency
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Eye disorders
Blurred Vision
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Eye disorders
Conjunctival Cyst, OS
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Eye disorders
Dry Eye
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Eye disorders
Floaters
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Eye disorders
Scleral Disorder
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Abdominal Bloating
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Bloating
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Dental Caries
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
27.3%
3/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
75.0%
6/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Chills
|
18.2%
2/11 • Approximately 6.5 years.
|
50.0%
3/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Edema Face
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Edema Limbs
|
18.2%
2/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Erythema At PICC Site
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Erythema On Scalp
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Erythematous Ulcer On Right Upper Pallet
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Excoriation Of Buttocks
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Excoriation Of Scrotum
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Fatigue
|
45.5%
5/11 • Approximately 6.5 years.
|
50.0%
3/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
General disorders
Fever
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Gait Disturbance
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Infusion Related Reaction
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Intermittent PICC Site Irritation
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Intermittent PICCsite Irritation
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Left Sided Head Numbness
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
General disorders
Localized Edema
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Blood Bicarbonate Decreased
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Blood LDH Increase
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Bone Marrow Hypocellular
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
18.2%
2/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
25.0%
2/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Elevated D-dimer
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Elevated Ferritin
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Elevated Fibrinogen
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Elevated Pro-BNP
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
54.5%
6/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
37.5%
3/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
5/11 • Approximately 6.5 years.
|
33.3%
2/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
66.7%
2/3 • Approximately 6.5 years.
|
|
Blood and lymphatic system disorders
Bicarbonate Decrease
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Musculoskeletal and connective tissue disorders
Scattered Pea Size Nodules Bilateral Calfs
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/11 • Approximately 6.5 years.
|
16.7%
1/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
0.00%
0/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
12.5%
1/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Dysphasia
|
18.2%
2/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Headache
|
54.5%
6/11 • Approximately 6.5 years.
|
50.0%
3/6 • Approximately 6.5 years.
|
50.0%
4/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Movements Involuntary
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/11 • Approximately 6.5 years.
|
0.00%
0/6 • Approximately 6.5 years.
|
0.00%
0/8 • Approximately 6.5 years.
|
33.3%
1/3 • Approximately 6.5 years.
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Phone: 4439273568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60