Trial Outcomes & Findings for Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting (NCT NCT05108805)
NCT ID: NCT05108805
Last Updated: 2025-03-27
Results Overview
The number of participants that received YESCARTA as outpatient therapy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
Approximately 6 weeks
Results posted on
2025-03-27
Participant Flow
Participant milestones
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Overall Study
T-cell expansion was not successful.
|
5
|
Baseline Characteristics
Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
Baseline characteristics by cohort
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=25 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 weeksThe number of participants that received YESCARTA as outpatient therapy
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Number of Participants That Received YESCARTA
|
20 Participants
|
PRIMARY outcome
Timeframe: at 72 hoursNumber of subjects that were admitted to hospital at 72 hours post infusion
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Required Hospitalization at 72 Hours Post Infusion
|
2 Participants
|
PRIMARY outcome
Timeframe: at 7 daysNumber of subjects that were admitted to the hospital at 7 days post infusion
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Required Hospitalization at 7 Days Post Infusion
|
19 Participants
|
PRIMARY outcome
Timeframe: at 14 daysNumber of subjects that were admitted to the hospital at 14 days post infusion
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Required Hospitalization at 14 Days Post Infusion
|
19 Participants
|
PRIMARY outcome
Timeframe: at 30 daysNumber of subjects that were admitted to hospital at 30 days post infusion
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Required Hospitalization at 30 Days Post Infusion
|
19 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 daysPopulation: This analysis includes all participants who consented to the study but did not receive YESCARTA as planned. Reasons the participants did not receive YESCARTA are listed.
Reasons as to why a participant did not receive YESCARTA in the out-patient setting
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=5 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Death from progressive disease
|
3 Participants
|
|
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Severe infection
|
1 Participants
|
|
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Performance status change
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 daysCount of participants that had cytokine release syndrome events
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Experienced Cytokine Release Syndrome Events
|
19 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 daysCount of participants that had an immune effector cell-associated neurotoxicity syndrome event
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events
|
8 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 daysCount of participants that were administered steroids during treatment
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Incidence of Steroid Administration During YESCARTA
|
20 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 daysPopulation: This was the total cost per patient for administering Yescarta on study.
Cost includes hospital clinic charges and CAR-T acquisition. It was pre-specified to report a single dollar amount that every participant was changed. The amount entered was the amount that each patient was charged. It was not planned to assess this amount separately for each participant.
Outcome measures
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=20 Participants
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Out-Patient Clinic Visit: Physical exam and review of all available data
Blood pressure and pulse oximeter: Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleucel: Axicabtagene Ciloleuce given by IV
Cyclophosphamide: Given IV
Fludarabine: Given IV
|
|---|---|
|
Cost Per Patient of Administering YESCARTA in the Out-patient Setting
|
392,237.75 dollars
|
Adverse Events
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Serious events: 6 serious events
Other events: 21 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=25 participants at risk
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
|
|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Nervous system disorders
Encephalopathy
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
General disorders
Fever
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Immune system disorders
Cytokine release syndrome
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
Other adverse events
| Measure |
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
n=25 participants at risk
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
Telemedicine Visit: A remote telemedicine visit with audio and video, using the internet with a nurse practitioner located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, HR, RR, SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Vital sign measurements: Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • Number of events 8 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Blood and lymphatic system disorders
White Blood Cell Decrease
|
12.0%
3/25 • Number of events 6 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Investigations
Neutrophil Count Decrease
|
40.0%
10/25 • Number of events 23 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
General disorders
Fatique
|
32.0%
8/25 • Number of events 9 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
General disorders
Fever
|
64.0%
16/25 • Number of events 19 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Investigations
Platelet Count Decreased
|
12.0%
3/25 • Number of events 3 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 5 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Vascular disorders
Hypotension
|
24.0%
6/25 • Number of events 8 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Nervous system disorders
Cognitive Disturbance
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Nervous system disorders
Encephalopathy
|
16.0%
4/25 • Number of events 6 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
General disorders
Non-Cardiac Chest Pain
|
8.0%
2/25 • Number of events 2 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
|
Immune system disorders
Cytokine Release Syndrome
|
60.0%
15/25 • Number of events 26 • From initiation of protocol-indicated treatment up to approximately 12 months.
|
Additional Information
Dr. Olalekan Oluwole
Vanderbilt University Medical Center
Phone: (615) 936-8422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place