Trial Outcomes & Findings for TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma (NCT NCT02652468)

Last Updated: 2022-01-05

Results Overview

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

At day 28 after transplantation

Results posted on

2022-01-05

Participant Flow

Patients of the University of Wisconsin Carbone Cancer Center were enrolled from March 2016 to June 2018.

Participant milestones

Participant milestones
Measure	Peripheral Blood Stem Cell Transplant PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg participant body weight (BW), Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Age, Customized 20-29 years	1 Participants n=5 Participants
Age, Customized 30-39 years	1 Participants n=5 Participants
Age, Customized 40-49 years	1 Participants n=5 Participants
Age, Customized 50-59 years	3 Participants n=5 Participants
Age, Customized 60-69 years	5 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 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	0 Participants n=5 Participants
Race (NIH/OMB) White	11 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	11 participants n=5 Participants

PRIMARY outcome

Timeframe: At day 28 after transplantation

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days	11 Participants

SECONDARY outcome

Timeframe: Day +100

The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria	3 Participants

SECONDARY outcome

Timeframe: Day +180

The number of participants with severe chronic GVHD by Day +180 will be reported.

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Number of Participants With Severe Chronic GVHD	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years after graft

Graft failure - defined as \< 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved.

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Number of Participants With Graft Failure	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years after graft

Treatment-related mortality is defined as death from any cause other than disease progression.

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Number of Participants With Treatment-related Mortality	4 Participants

SECONDARY outcome

Timeframe: Median follow up of 1689 days

Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow,

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Progression-free Survival	352 days Interval 27.0 to 1875.0

SECONDARY outcome

Timeframe: Median follow up of 1689 days

Outcome measures

Outcome measures
Measure	Peripheral Blood Stem Cell Transplant n=11 Participants PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Overall Survival (OS)	352 days Interval 27.0 to 1875.0

Adverse Events

Peripheral Blood Stem Cell Transplant

Serious events: 10 serious events

Other events: 11 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Peripheral Blood Stem Cell Transplant n=11 participants at risk PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Cardiac disorders Cardiac Arrest	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Pericardial effusion	27.3% 3/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Right ventricular dysfunction	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Infections and infestations - Other, specify	45.5% 5/11 • Number of events 11 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Sepsis	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Platelet count decreased	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Acute kidney injury	27.3% 3/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Atrial Fibrillation	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Atrial Flutter	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Heart Failure	27.3% 3/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Lung Infection	27.3% 3/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	27.3% 3/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Thromboembolitic Event	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Hematoma	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Hypotension	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Anorexia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Blood Bilirubin Increased	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Death NOS	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Immune system disorders Immune System Disorders - Other	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.

Other adverse events

Other adverse events
Measure	Peripheral Blood Stem Cell Transplant n=11 participants at risk PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).
Gastrointestinal disorders Abdominal pain	45.5% 5/11 • Number of events 12 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Acidosis	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Activated partial thromboplastin time prolonged	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Acute kidney injury	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Alanine aminotransferase increased	54.5% 6/11 • Number of events 20 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Alkaline phosphatase increased	36.4% 4/11 • Number of events 9 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Blood and lymphatic system disorders Anemia	100.0% 11/11 • Number of events 59 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Anorexia	27.3% 3/11 • Number of events 7 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Psychiatric disorders Anxiety	36.4% 4/11 • Number of events 7 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Aspartate aminotransferase increased	72.7% 8/11 • Number of events 26 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Aspiration	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Atelectasis	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Atrial fibrillation	27.3% 3/11 • Number of events 8 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Atrial flutter	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Back pain	36.4% 4/11 • Number of events 5 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Bloating	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	18.2% 2/11 • Number of events 10 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Blood bilirubin increased	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Eye disorders Blurred vision	9.1% 1/11 • Number of events 5 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Bone pain	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Injury, poisoning and procedural complications Bruising	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Buttock pain	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Cardiac arrest	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Cardiac troponin I increased	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Chest pain - cardiac	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Chest wall pain	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Chills	63.6% 7/11 • Number of events 12 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Cholesterol high	9.1% 1/11 • Number of events 8 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Chronic kidney disease	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Colitis	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Psychiatric disorders Confusion	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Constipation	45.5% 5/11 • Number of events 9 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Cough	54.5% 6/11 • Number of events 15 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Creatinine increased	72.7% 8/11 • Number of events 24 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Psychiatric disorders Delirium	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Depressed level of consciousness	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Diarrhea	100.0% 11/11 • Number of events 33 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Dizziness	54.5% 6/11 • Number of events 16 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Dry mouth	45.5% 5/11 • Number of events 16 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Dysarthria	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Dysgeusia	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Dyspepsia	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Dysphagia	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	81.8% 9/11 • Number of events 20 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Edema face	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Edema limbs	72.7% 8/11 • Number of events 15 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Ejection fraction decreased	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Electrocardiogram QT corrected interval prolonged	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Enterocolitis	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Enterocolitis infectious	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Reproductive system and breast disorders Erectile dysfunction	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Erythema multiforme	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Eye disorders Eye disorders - Other, specify	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Facial pain	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Fatigue	81.8% 9/11 • Number of events 34 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Blood and lymphatic system disorders Febrile neutropenia	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Fecal incontinence	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Fever	100.0% 11/11 • Number of events 19 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Eye disorders Floaters	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Flu like symptoms	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Flushing	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders General disorders and administration site conditions - Other, specify	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations GGT increased	27.3% 3/11 • Number of events 6 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Glucose intolerance	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Headache	81.8% 9/11 • Number of events 21 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Heart failure	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Hematuria	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Hemoglobinuria	18.2% 2/11 • Number of events 5 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Blood and lymphatic system disorders Hemolytic uremic syndrome	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Hiccups	27.3% 3/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypercalcemia	9.1% 1/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hyperglycemia	27.3% 3/11 • Number of events 19 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hyperkalemia	27.3% 3/11 • Number of events 8 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypermagnesemia	45.5% 5/11 • Number of events 6 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypernatremia	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Hypertension	27.3% 3/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypertriglyceridemia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hyperuricemia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 11/11 • Number of events 46 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypocalcemia	45.5% 5/11 • Number of events 15 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypokalemia	81.8% 9/11 • Number of events 24 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypomagnesemia	54.5% 6/11 • Number of events 10 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hyponatremia	63.6% 7/11 • Number of events 24 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Hypophosphatemia	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Hypotension	54.5% 6/11 • Number of events 13 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Hypothermia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Endocrine disorders Hypothyroidism	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	36.4% 4/11 • Number of events 9 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Immune system disorders Immune system disorders - Other, specify	36.4% 4/11 • Number of events 9 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Infections and infestations - Other, specify	45.5% 5/11 • Number of events 10 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations INR increased	27.3% 3/11 • Number of events 6 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Psychiatric disorders Insomnia	45.5% 5/11 • Number of events 13 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Left ventricular systolic dysfunction	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Lethargy	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Lipase increased	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Localized edema	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Lung infection	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Lymphocyte count decreased	100.0% 11/11 • Number of events 58 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Malabsorption	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Malaise	36.4% 4/11 • Number of events 6 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Mucositis oral	36.4% 4/11 • Number of events 5 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Multi-organ failure	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	36.4% 4/11 • Number of events 6 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Nausea	100.0% 11/11 • Number of events 39 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Neck pain	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Neutrophil count decreased	100.0% 11/11 • Number of events 29 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Non-cardiac chest pain	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Oral pain	27.3% 3/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
General disorders Pain	63.6% 7/11 • Number of events 13 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Palpitations	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Papulopustular rash	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Paroxysmal atrial tachycardia	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Pericardial effusion	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Peripheral motor neuropathy	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Peripheral sensory neuropathy	9.1% 1/11 • Number of events 5 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Platelet count decreased	100.0% 11/11 • Number of events 59 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	27.3% 3/11 • Number of events 7 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Presyncope	18.2% 2/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Proctitis	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Productive cough	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Proteinuria	9.1% 1/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	27.3% 3/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Rash acneiform	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	81.8% 9/11 • Number of events 20 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Rectal hemorrhage	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Renal and urinary disorders - Other, specify	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Salivary duct inflammation	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Sepsis	18.2% 2/11 • Number of events 4 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Sinus tachycardia	36.4% 4/11 • Number of events 9 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Sinusitis	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Skin atrophy	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Skin and subcutaneous tissue disorders Skin ulceration	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Somnolence	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Sore throat	54.5% 6/11 • Number of events 10 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Syncope	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Nervous system disorders Tremor	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Upper respiratory infection	27.3% 3/11 • Number of events 3 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Urinary frequency	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Urinary incontinence	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Urinary retention	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Urinary tract pain	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Renal and urinary disorders Urinary urgency	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Urine output decreased	9.1% 1/11 • Number of events 1 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Cardiac disorders Ventricular tachycardia	9.1% 1/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Gastrointestinal disorders Vomiting	72.7% 8/11 • Number of events 12 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations Weight loss	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Respiratory, thoracic and mediastinal disorders Wheezing	18.2% 2/11 • Number of events 2 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.
Investigations White blood cell decreased	90.9% 10/11 • Number of events 25 • up to 5.5 years Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.

Additional Information

Vaishalee Kenkre

University of Madison Carbone Cancer Center

Phone: (608) 263-1699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place