Trial Outcomes & Findings for A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity (NCT NCT04150913)

Last Updated: 2025-11-25

Results Overview

The incidence of grade 2+ neurotoxicity is reported below and was assessed using CTCAE (Common Terminology Criteria for Adverse Events) v4.04 criteria. Neurotoxicity is a serious side effect of cancer treatments that can impact the central and peripheral nervous systems. Neurotoxicity manifestations vary and can include confusion, obtundation, seizures, hallucinations, aphasia, ataxia, and more rarely, profound cerebral edema.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

30 Days

Results posted on

2025-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Anakinra and Axicabtagene Ciloleucel Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 13. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 13. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Age, Continuous	64 years STANDARD_DEVIATION 9.33 • n=45 Participants
Sex: Female, Male Female	7 Participants n=45 Participants
Sex: Female, Male Male	8 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants
Race (NIH/OMB) White	10 Participants n=45 Participants
Race (NIH/OMB) More than one race	2 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=45 Participants
International Prognostic Index	3 Score (0-5) n=45 Participants
Eastern Cooperative Oncology Group Grade 0	5 Participants n=45 Participants
Eastern Cooperative Oncology Group Grade 1	10 Participants n=45 Participants
Histology tFL	5 Participants n=45 Participants
Histology DLBCL NOS	9 Participants n=45 Participants
Histology HGBCL	1 Participants n=45 Participants
Number of prior regimens Primary refractory disease	3 Participants n=45 Participants
Number of prior regimens Prior autologous HSCT	3 Participants n=45 Participants
Tumor burden, Baseline LDH (U/L)	223 U/L n=45 Participants
Tumor burden, Baseline SPD (mm2)	2239 mm2 n=45 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: Neurotoxicity, Max Grade

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Rate of Neurotoxicity as Per CTCAE v4.03 Criteria Grade 1	3 Participants
Rate of Neurotoxicity as Per CTCAE v4.03 Criteria Grade 2	2 Participants
Rate of Neurotoxicity as Per CTCAE v4.03 Criteria Grade 3-4	5 Participants
Rate of Neurotoxicity as Per CTCAE v4.03 Criteria Grade 5	1 Participants
Rate of Neurotoxicity as Per CTCAE v4.03 Criteria Did not experience Neurotoxicity	4 Participants

SECONDARY outcome

Timeframe: 24 Months

Objective response rate (ORR) is defined as the incidence of either a complete response (CR) or a partial response (PR) by the revised IWG Response Criteria for Malignant Lymphoma. All participants who don't meet the ORR criteria by the analysis data cutoff date will be considered non-responders. * CR = complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy; PET scan negative; lymph nodes/nodal masses regressed to normal size; normal size spleen/liver on CT scan; bone marrow aspirate and biopsy shows no evidence of disease by morphology or negative by IHC. * PR = ≥ 50% decrease in sum of the product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no size increase of nodes/liver/spleen; no new sites of disease; post-treatment PET scan positive in ≥ 1 previously involved site.

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Objective Response Rate Overall Response Rate	13 Participants
Objective Response Rate Complete Response	7 Participants
Objective Response Rate Partial Response	6 Participants

SECONDARY outcome

Timeframe: first objective response to disease progression death regardless of cause up 24 Months

Population: Progression Free Survival (PFS); Overall Survival OS)

Among participants who experience an objective response, duration of response (DOR) is defined as the date of their first objective response to disease progression per the revised IWG Response Criteria for Malignant Lymphoma, or death regardless of cause. Participants not meeting the criteria for progressive disease (PD) or death by the analysis data cutoff date will be censored at their last evaluable disease assessment date and their response will be noted as ongoing. \* PD = ≥ 50% increase from nadir in the sum of the products of at least two lymph nodes; ≥ 50% increase in product of the diameters of single node; new lesion \>1.5 cm; ≥ 50% size increase of splenic/hepatic nodules; ≥ 50% increase in longest diameter of any single previously identified node more than 1 cm in its short axis; PET scan positive

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Duration of Response PFS at 6 months	58.2 percentage of participants Interval 29.4 to 78.7
Duration of Response PFS at 12 months	42.4 percentage of participants Interval 16.9 to 66.1
Duration of Response OS at 6 months	79.4 percentage of participants Interval 48.8 to 92.9
Duration of Response OS at 12 months	64.2 percentage of participants Interval 33.9 to 83.4

SECONDARY outcome

Timeframe: infusion date to the date of disease progression or death from any cause up 24 Months

Population: Progression Free Survival

Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for progression-free survival time

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Progression-free Survival PFS at 6 months	58.2 percentage of participants Interval 29.4 to 78.7
Progression-free Survival PFS at 12 months	42.4 percentage of participants Interval 16.9 to 66.1

SECONDARY outcome

Timeframe: time from axicabtagene ciloleucel infusion to the date of death or analysis data cutoff date will be censored at last contact date up to 24 months.

Population: Overall Survival

Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for OS.

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Overall Survival OS at 6 months	79.4 percentage of participants Interval 48.8 to 92.9
Overall Survival OS at 12 months	64.2 percentage of participants Interval 33.9 to 83.4

SECONDARY outcome

Timeframe: 24 Months

Population: Participants who experienced Adverse Events (AE), Grade 3 or higher

Subject incidence rates of adverse events including all, serious, fatal, CTCAE version 4.03 Grade 3 or higher and treatment related AEs reported throughout the conduct of the study will be tabulated by preferred term and system organ class

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Endocrine disorders : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Gastrointestinal disorders : Grade 3	4 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher General disorders and administration site conditions : Grade 3	5 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Hepatobiliary disorders : Grade 3	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Immune system disorders : Grade 3	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Investigations : Grade 3	9 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Investigations : Grade 4	9 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Metabolism and nutrition disorders : Grade 3	9 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Metabolism and nutrition disorders : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Musculoskeletal and connective tissue disorders : Grade 3	2 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Psychiatric disorders : Grade 3	2 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Renal and urinary disorders : Grade 3	2 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Respiratory, thoracic and mediastinal disorders : Grade 3	5 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Vascular disorders : Grade 3	4 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Vascular disorders : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Ear and labyrinth disorders : Grade 3	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Endocrine disorders : Grade 3	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Infections and Infestations: Grade 3	4 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Infections and Infestations : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Infections and Infestations : Grade 5	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Nervous System Disorders : Grade 3	6 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Nervous System Disorders : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Blood and lymphatic system disorders : Grade 3	9 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Blood and lymphatic system disorders : Grade 4	1 Participants
Number of Participants With Adverse Events CTCAE Version 4.03 Grade 3 or Higher Cardiac disorders : Grade 3	1 Participants

SECONDARY outcome

Timeframe: Within 30 days after infusion

The incidence of max grade 2+ CRS will be assessed

Outcome measures

Outcome measures
Measure	Anakinra and Axicabtagene Ciloleucel n=15 Participants Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 6. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Rate of Cytokine Release Syndrome (CRS) as Per Lee 2014 for CRS Grade 1	6 Participants
Rate of Cytokine Release Syndrome (CRS) as Per Lee 2014 for CRS Grade 2	6 Participants
Rate of Cytokine Release Syndrome (CRS) as Per Lee 2014 for CRS Grade 3	1 Participants
Rate of Cytokine Release Syndrome (CRS) as Per Lee 2014 for CRS Grade 4	1 Participants
Rate of Cytokine Release Syndrome (CRS) as Per Lee 2014 for CRS No CRS	1 Participants

Adverse Events

Anakinra and Axicabtagene Ciloleucel

Serious events: 9 serious events

Other events: 15 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Anakinra and Axicabtagene Ciloleucel n=15 participants at risk Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 13. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Infections and infestations Upper Respiratory Infection	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Hypotension	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Anemia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Vasovagal Reaction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Febrile Neutropenia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Urinary Tract Infection	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome (ICANS)	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Cytokine Release Syndrome (CRS)	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.

Other adverse events

Other adverse events
Measure	Anakinra and Axicabtagene Ciloleucel n=15 participants at risk Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period Anakinra: Subcutaneous, dosage per protocol. Day 0 through Day 13. Axicabtagene Ciloleucel: Once, intravenous infusion, dosage per protocol
Gastrointestinal disorders Dyspepsia	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Dysphagia	6.7% 1/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Abdominal pain	40.0% 6/15 • Number of events 10 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Bloating	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Diarrhea	60.0% 9/15 • Number of events 11 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Dry Mouth	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Fecal incontinence	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Gastroesophageal Reflux Disease	26.7% 4/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Nausea	73.3% 11/15 • Number of events 16 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Small Intestinal Obstruction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Vomiting	26.7% 4/15 • Number of events 7 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Ulcerative Colitis	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Hemoptysis/Melena	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Gastrointestinal disorders Constipation	73.3% 11/15 • Number of events 13 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Anemia	73.3% 11/15 • Number of events 41 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Febrile Neutropenia	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Leukopenia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Blood and lymphatic system disorders Thrombocytopenia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Atrial Fibrillation	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Tachycardia-Bradycardia Syndrome	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Pulmonary Embolism	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Left Ventricular Systolic Dysfunction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Sinus Bradycardia	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Sinus Tachycardia	13.3% 2/15 • Number of events 7 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Cardiac disorders Ventricular Tachycardia	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Ear and labyrinth disorders Hearing Impaired	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Ear and labyrinth disorders Vertigo	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Endocrine disorders Adrenal Insufficiency	6.7% 1/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Endocrine disorders Hyperthyroidism	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Eye disorders Blurred Vision	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Eye disorders Eye Irritation	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Eye disorders Right Conjunctival Hemorrhage	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Eye disorders Periorbital Edema	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Eye disorders Vision Decreased	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Chills	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Edema Limbs	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Fatigue	100.0% 15/15 • Number of events 23 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Fever	46.7% 7/15 • Number of events 18 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Flu like symptoms	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Gait Disturbance	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Generalized Edema	26.7% 4/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Injection Site Reaction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Localized Edema	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Malaise	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Pain	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Hickman Line Irritation	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Central Line Irritation	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Distributive Shock	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
General disorders Weakness	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Hepatobiliary disorders Gallbladder Obstruction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Hepatobiliary disorders Portal Vein Thrombosis	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Immune system disorders Cytokine Release Syndrome	93.3% 14/15 • Number of events 22 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Immune system disorders Seasonal Allergies	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Immune system disorders Systemic Inflammatory Response Syndrome	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Immune system disorders Hypogammaglobulinemia	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Bacteremia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Enterocolitis Infectious	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations COVID Infection	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Otitis Media	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Sepsis	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Shingles	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Thrush	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Infections and infestations Urinary Tract Infection	13.3% 2/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Injury, poisoning and procedural complications Bruising	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Injury, poisoning and procedural complications Fall	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Activated Partial Thromboplastin Time-Prolonged	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Alanine Aminotransferase Increased	33.3% 5/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Alkaline Phosphatase Increased	26.7% 4/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Aspartate Aminotransferase Increased	26.7% 4/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Blood Bilirubin Increased	6.7% 1/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Creatinine Increased	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Fibrinogen Decreased	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Lipase Increased	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Hypogammaglobulinemia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Lymphocyte Count Decreased	46.7% 7/15 • Number of events 37 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Neutrophil Count Decreased	60.0% 9/15 • Number of events 40 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Platelet Count Decreased	53.3% 8/15 • Number of events 24 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Serum Amylase Increased	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations Weight Loss	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Investigations White Blood Cell Decreased	6.7% 1/15 • Number of events 10 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Alkalosis	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Anorexia	73.3% 11/15 • Number of events 20 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypercalcemia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hyperglycemia	20.0% 3/15 • Number of events 6 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hyperlipidemia	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypernatremia	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypertriglyceridemia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypoalbuminemia	26.7% 4/15 • Number of events 9 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypocalcemia	33.3% 5/15 • Number of events 9 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypokalemia	20.0% 3/15 • Number of events 6 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypomagnesemia	60.0% 9/15 • Number of events 10 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hyponatremia	26.7% 4/15 • Number of events 7 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Metabolism and nutrition disorders Hypophosphatemia	53.3% 8/15 • Number of events 13 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Back Pain	40.0% 6/15 • Number of events 8 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Bone Pain	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	26.7% 4/15 • Number of events 6 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Generalized Upper Body Musculoskeletal Pain	6.7% 1/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Musculoskeletal and connective tissue disorders Intermittent Jaw Pain	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Depressed Level of Consciousness	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Dizziness	46.7% 7/15 • Number of events 9 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Dysarthria	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Dysgeusia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Dysphasia	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Edema Cerebral	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Encephalopathy	20.0% 3/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Headache	66.7% 10/15 • Number of events 17 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Memory Impairment	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Muscle Weakness Right-Sided	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Olfactory Nerve Disorder	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Paresthesia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Peripheral Motor Neuropathy	26.7% 4/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Peripheral Sensory Neuropathy	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Somnolence	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Tremor	33.3% 5/15 • Number of events 8 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Vasovagal Reaction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Hyperalgesia	6.7% 1/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Aphasia	6.7% 1/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Altered Mental Status	6.7% 1/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Word Finding Difficulties	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Peripheral Neuropathy	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Intermittent Delayed Word	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Emotional Lability	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Expressive Aphasia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Subarachnoid Hemorrhage	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Myoclonus	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Neurotoxicity	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Agitation	13.3% 2/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Anxiety	33.3% 5/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Confusion	33.3% 5/15 • Number of events 12 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Delirium	20.0% 3/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Depression	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Hallucinations	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Psychiatric disorders Insomnia	46.7% 7/15 • Number of events 7 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Acute Kidney Injury	20.0% 3/15 • Number of events 4 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Dysuria	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Urinary Frequency	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Urinary Incontinence	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Urinary Retention	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Urinary Tract Obstruction	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Renal and urinary disorders Chronic Kidney Disease	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Reproductive system and breast disorders Secondary Infertility	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Aspiration	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 3/15 • Number of events 5 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	6.7% 1/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Sinus Pain	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Respiratory, thoracic and mediastinal disorders Sore Throat	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Skin and subcutaneous tissue disorders Pruritus	13.3% 2/15 • Number of events 2 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Skin and subcutaneous tissue disorders Skin Ulceration	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Skin and subcutaneous tissue disorders Leg Petechia	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Hypertension	20.0% 3/15 • Number of events 3 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Hypotension	40.0% 6/15 • Number of events 18 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Thromboembolic Event	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Right Upper Extremity DVT	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Vascular disorders Right Lower Extremity Deep Vein Thrombosis	6.7% 1/15 • Number of events 1 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome (ICANS)	66.7% 10/15 • Number of events 32 • All adverse events observed by the investigator or reported by the subject that occur from enrollment through 3 months were monitored and reported. After 3 months, only targeted adverse events including (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) were monitored and reported for 24 months.

Additional Information

Director, Cellular Immunotherapy Program

Massachusetts General Hospital

Phone: 857-367-1486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place