Trial Outcomes & Findings for Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy (NCT NCT03701308)

NCT ID: NCT03701308

Last Updated: 2026-01-21

Results Overview

EFS is defined as the time from the date of randomization to the first of failure to achieve a complete remission (CR)/ CR with incomplete blood count recovery (CRi) during induction, relapse, or death due to any cause, with patients last known to be alive and event-free censored at the date of last contact.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2/PHASE3
• Target enrollment: 267 participants
• Primary outcome timeframe: 67 months
• Results posted on: 2026-01-21

Participant Flow

Participant milestones

Measure	Arm I (Daunorubicin, Cytarabine) INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
Overall Study STARTED	136	131
Overall Study COMPLETED	134	129
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Arm I (Daunorubicin, Cytarabine) INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
Overall Study Ineligible	2	2

Baseline Characteristics

Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Baseline characteristics by cohort

Measure	Arm I (Daunorubicin, Cytarabine) n=136 Participants INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=131 Participants INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Total n=267 Participants Total of all reporting groups
Age, Continuous	67.1 years n=37 Participants	66.8 years n=44 Participants	66.9 years n=40 Participants
Sex: Female, Male Female	50 Participants n=37 Participants	60 Participants n=44 Participants	110 Participants n=40 Participants
Sex: Female, Male Male	86 Participants n=37 Participants	71 Participants n=44 Participants	157 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=37 Participants	7 Participants n=44 Participants	11 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=37 Participants	109 Participants n=44 Participants	230 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=37 Participants	15 Participants n=44 Participants	26 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	2 Participants n=37 Participants	2 Participants n=44 Participants	4 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	10 Participants n=37 Participants	12 Participants n=44 Participants	22 Participants n=40 Participants
Race (NIH/OMB) White	119 Participants n=37 Participants	99 Participants n=44 Participants	218 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants	17 Participants n=44 Participants	22 Participants n=40 Participants

PRIMARY outcome

Timeframe: 67 months

EFS is defined as the time from the date of randomization to the first of failure to achieve a complete remission (CR)/ CR with incomplete blood count recovery (CRi) during induction, relapse, or death due to any cause, with patients last known to be alive and event-free censored at the date of last contact.

Outcome measures

Measure	Arm I (Daunorubicin, Cytarabine) n=134 Participants INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=129 Participants INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
Event-free Survival (EFS)	5.4 months Interval 3.3 to 8.3	9.4 months Interval 5.2 to 13.8

PRIMARY outcome

Timeframe: 67 months

Population: All registered patients

Will be measured from the date of randomization to death from any cause, with patients last known to be alive censored at the date of last contact.

Outcome measures

Measure	Arm I (Daunorubicin, Cytarabine) n=136 Participants INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=131 Participants INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
Overall Survival (OS)	19.8 Months Interval 14.6 to 43.3	23.6 Months Interval 15.1 to 35.3

SECONDARY outcome

Timeframe: 24 months

Population: All eligible patients

Event Free Survival will be defined as the time from patient registration to treatment failure, progression, or death. The proportion of patients alive and event free at 24 months will be reported.

Outcome measures

Measure	Arm I (Daunorubicin, Cytarabine) n=134 Participants INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=129 Participants INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
EFS Rate at 24 Months	0.290 proportion of patients Interval 0.215 to 0.39	0.326 proportion of patients Interval 0.249 to 0.426

SECONDARY outcome

Timeframe: Up to 5 years

Sensitivity analyses will be conducted. In addition, the proportion of patients who received transplantation in the two arms will be summarized and compared using a chi-square test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline up to 5 years

Non-parametric methods such as Kaplan-Meier and log-rank tests will be used within each subgroup. Univariate/multivariate Cox models will be fit within each subgroups; hazard ratios will be used to quantify the treatment effect within each subgroup, along with the 95% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from achieving a complete response to time of relapse or death, assessed up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

The associations between these baseline factors and CR, EFS, DFS, and OS will be analyzed using Kaplan-Meier curves, log-rank test, contingency table and chi-square test whenever appropriate. Multivariable analysis including Cox proportional hazards models and logistic regression models will be used as well to evaluate the associations.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Daunorubicin, Cytarabine)

Serious events: 12 serious events

Other events: 130 other events

Deaths: 47 deaths

Arm II (Uproleselan, Daunorubicin, Cytarabine)

Serious events: 12 serious events

Other events: 126 other events

Deaths: 84 deaths

Serious adverse events

Measure	Arm I (Daunorubicin, Cytarabine) n=136 participants at risk INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=131 participants at risk INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
General disorders Death NOS	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Disease progression	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Multi-organ failure	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Sudden death NOS	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Cardiac arrest	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Heart failure	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Infections and infestations - Oth spec	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Lung infection	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Sepsis	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Intracranial hemorrhage	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Acute kidney injury	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.

Other adverse events

Measure	Arm I (Daunorubicin, Cytarabine) n=136 participants at risk INDUCTION: Patients receive daunorubicin IV on days 1-3 and cytarabine via CIVI over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-2 and cytarabine CIVI over 12 hours on days 1-5. CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.	Arm II (Uproleselan, Daunorubicin, Cytarabine) n=131 participants at risk INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-8, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo MUGA or ECHO during baseline, and bone marrow aspirate, bone marrow biopsy, and blood collection throughout the study.
Gastrointestinal disorders Anal ulcer	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Ascites	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Bloating	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Colitis	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Constipation	20.6% 28/136 • Number of events 36 • Adverse events were followed for 25 months and mortality was followed for 67 months.	16.8% 22/131 • Number of events 32 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Dental caries	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Diarrhea	61.0% 83/136 • Number of events 117 • Adverse events were followed for 25 months and mortality was followed for 67 months.	60.3% 79/131 • Number of events 119 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Dry mouth	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Dyspepsia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.9% 9/131 • Number of events 12 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Dysphagia	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Enterocolitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Esophagitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Fecal incontinence	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Flatulence	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gastritis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gastroesophageal reflux disease	4.4% 6/136 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gastrointestinal pain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Gingival pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Hemorrhoids	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Mucositis oral	34.6% 47/136 • Number of events 78 • Adverse events were followed for 25 months and mortality was followed for 67 months.	38.2% 50/131 • Number of events 72 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Nausea	59.6% 81/136 • Number of events 128 • Adverse events were followed for 25 months and mortality was followed for 67 months.	61.8% 81/131 • Number of events 154 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Oral pain	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Proctitis	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Rectal hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Rectal pain	2.9% 4/136 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Rectal ulcer	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Retroperitoneal hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Stomach pain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Toothache	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Typhlitis	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Hepatobiliary disorders Cholecystitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Hepatobiliary disorders Hepatic failure	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Immune system disorders Allergic reaction	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Abdominal infection	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Anorectal infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Appendicitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Bacteremia	6.6% 9/136 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Bone infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Bronchial infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Catheter related infection	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Conjunctivitis	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Endocarditis infective	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Enterocolitis infectious	4.4% 6/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	5.3% 7/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Folliculitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Gum infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Bruising	2.9% 4/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Fall	3.7% 5/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Fracture	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations INR increased	4.4% 6/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Investigations - Other, specify	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Lymphocyte count decreased	46.3% 63/136 • Number of events 275 • Adverse events were followed for 25 months and mortality was followed for 67 months.	51.1% 67/131 • Number of events 316 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Lymphocyte count increased	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Neutrophil count decreased	61.8% 84/136 • Number of events 332 • Adverse events were followed for 25 months and mortality was followed for 67 months.	67.2% 88/131 • Number of events 354 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Platelet count decreased	75.7% 103/136 • Number of events 472 • Adverse events were followed for 25 months and mortality was followed for 67 months.	84.0% 110/131 • Number of events 508 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Urine output decreased	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Weight gain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Weight loss	4.4% 6/136 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 19 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations White blood cell decreased	75.0% 102/136 • Number of events 419 • Adverse events were followed for 25 months and mortality was followed for 67 months.	78.6% 103/131 • Number of events 478 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Acidosis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Alkalosis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Anorexia	19.1% 26/136 • Number of events 34 • Adverse events were followed for 25 months and mortality was followed for 67 months.	29.8% 39/131 • Number of events 54 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypomagnesemia	5.1% 7/136 • Number of events 12 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyponatremia	8.1% 11/136 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.	7.6% 10/131 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypophosphatemia	9.6% 13/136 • Number of events 15 • Adverse events were followed for 25 months and mortality was followed for 67 months.	11.5% 15/131 • Number of events 23 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Chronic kidney disease	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Dysuria (painful urination)	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Glucosuria	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Hematuria	2.2% 3/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Proteinuria	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Anemia	72.8% 99/136 • Number of events 359 • Adverse events were followed for 25 months and mortality was followed for 67 months.	78.6% 103/131 • Number of events 405 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	2.2% 3/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Anal fistula	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Febrile neutropenia	78.7% 107/136 • Number of events 137 • Adverse events were followed for 25 months and mortality was followed for 67 months.	72.5% 95/131 • Number of events 149 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Leukocytosis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Atrial fibrillation	4.4% 6/136 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Atrial flutter	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Cardiac disorders - Other, specify	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Chest pain - cardiac	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Heart failure	2.9% 4/136 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Myocardial infarction	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Palpitations	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Pericardial effusion	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Pericarditis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Sinus bradycardia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	5.3% 7/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Sinus tachycardia	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.1% 8/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Cardiac disorders Ventricular fibrillation	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Ear and labyrinth disorders Ear and labyrinth disorders - Oth spec	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Ear and labyrinth disorders Ear pain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Ear and labyrinth disorders Hearing impaired	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Endocrine disorders Adrenal insufficiency	0.74% 1/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Endocrine disorders Hyperthyroidism	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Blurred vision	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Dry eye	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Eye disorders - Other, specify	2.9% 4/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Eye pain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Floaters	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Keratitis	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Periorbital edema	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Vision decreased	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Eye disorders Vitreous hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Abdominal pain	14.7% 20/136 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 13 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Anal fissure	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Gastrointestinal disorders Vomiting	8.1% 11/136 • Number of events 15 • Adverse events were followed for 25 months and mortality was followed for 67 months.	10.7% 14/131 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Chills	6.6% 9/136 • Number of events 13 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.9% 9/131 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Edema face	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Edema limbs	8.8% 12/136 • Number of events 17 • Adverse events were followed for 25 months and mortality was followed for 67 months.	17.6% 23/131 • Number of events 27 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Fatigue	33.8% 46/136 • Number of events 73 • Adverse events were followed for 25 months and mortality was followed for 67 months.	36.6% 48/131 • Number of events 85 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Fever	14.7% 20/136 • Number of events 25 • Adverse events were followed for 25 months and mortality was followed for 67 months.	18.3% 24/131 • Number of events 35 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Flu like symptoms	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Gait disturbance	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Gen disord and admin site conds-Oth spec	5.1% 7/136 • Number of events 30 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.1% 8/131 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Generalized edema	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Infusion site extravasation	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Localized edema	1.5% 2/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Malaise	2.2% 3/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	5.3% 7/131 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Non-cardiac chest pain	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
General disorders Pain	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.1% 8/131 • Number of events 12 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Infections and infestations - Oth spec	11.0% 15/136 • Number of events 19 • Adverse events were followed for 25 months and mortality was followed for 67 months.	15.3% 20/131 • Number of events 32 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Lung infection	10.3% 14/136 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.	12.2% 16/131 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Nail infection	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Otitis externa	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Otitis media	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Papulopustular rash	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Pharyngitis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Rash pustular	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Sepsis	17.6% 24/136 • Number of events 27 • Adverse events were followed for 25 months and mortality was followed for 67 months.	14.5% 19/131 • Number of events 24 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Sinusitis	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Skin infection	4.4% 6/136 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Thrush	6.6% 9/136 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Tooth infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Upper respiratory infection	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Urinary tract infection	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Infections and infestations Wound infection	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Infusion related reaction	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Inj, pois and proced complic - Oth spec	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Activated partial throm time prolonged	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Alanine aminotransferase increased	48.5% 66/136 • Number of events 130 • Adverse events were followed for 25 months and mortality was followed for 67 months.	55.0% 72/131 • Number of events 164 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Alkaline phosphatase increased	4.4% 6/136 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Aspartate aminotransferase increased	42.6% 58/136 • Number of events 101 • Adverse events were followed for 25 months and mortality was followed for 67 months.	51.1% 67/131 • Number of events 126 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Blood bilirubin increased	39.0% 53/136 • Number of events 95 • Adverse events were followed for 25 months and mortality was followed for 67 months.	44.3% 58/131 • Number of events 85 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Blood lactate dehydrogenase increased	2.2% 3/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Cardiac troponin I increased	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Creatinine increased	8.8% 12/136 • Number of events 18 • Adverse events were followed for 25 months and mortality was followed for 67 months.	7.6% 10/131 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations ECG QT corrected interval prolonged	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Ejection fraction decreased	4.4% 6/136 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations Fibrinogen decreased	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Investigations GGT increased	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Blood bicarbonate decreased	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Dehydration	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypercalcemia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyperglycemia	11.8% 16/136 • Number of events 26 • Adverse events were followed for 25 months and mortality was followed for 67 months.	14.5% 19/131 • Number of events 31 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyperkalemia	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.1% 8/131 • Number of events 8 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyperlipidemia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypermagnesemia	2.2% 3/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypernatremia	2.9% 4/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyperphosphatemia	4.4% 6/136 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 12 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hyperuricemia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypoalbuminemia	25.7% 35/136 • Number of events 53 • Adverse events were followed for 25 months and mortality was followed for 67 months.	23.7% 31/131 • Number of events 57 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypocalcemia	21.3% 29/136 • Number of events 44 • Adverse events were followed for 25 months and mortality was followed for 67 months.	16.8% 22/131 • Number of events 48 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypoglycemia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Hypokalemia	25.7% 35/136 • Number of events 50 • Adverse events were followed for 25 months and mortality was followed for 67 months.	26.0% 34/131 • Number of events 65 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Metabolism, nutrition disord - Oth spec	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Back pain	2.9% 4/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.4% 6/136 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Muscle cramp	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Musculoskeletal, conn tissue - Oth spec	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Myositis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Neck pain	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Musculoskeletal and connective tissue disorders Pain in extremity	4.4% 6/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Amnesia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Ataxia	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Cognitive disturbance	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Dizziness	7.4% 10/136 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.	10.7% 14/131 • Number of events 15 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Dysarthria	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Dysgeusia	2.9% 4/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	4.6% 6/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Encephalopathy	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Headache	8.8% 12/136 • Number of events 18 • Adverse events were followed for 25 months and mortality was followed for 67 months.	19.1% 25/131 • Number of events 35 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Intracranial hemorrhage	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Lethargy	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Memory impairment	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Paresthesia	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Peripheral motor neuropathy	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Peripheral sensory neuropathy	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Presyncope	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Reversbl posterior leukoenceph syndrome	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Somnolence	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Stroke	0.74% 1/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Syncope	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	5.3% 7/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Nervous system disorders Tremor	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Agitation	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Anxiety	5.1% 7/136 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.1% 8/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Confusion	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Delirium	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Depression	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Hallucinations	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Insomnia	4.4% 6/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 13 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Personality change	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Psychiatric disorders Psychiatric disorders - Other, specify	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Acute kidney injury	3.7% 5/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Bladder spasm	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Renal and urinary disorders - Oth spec	1.5% 2/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Urinary frequency	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Urinary incontinence	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Urinary retention	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Renal and urinary disorders Urine discoloration	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Reproductive system and breast disorders Penile pain	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Reproductive system and breast disorders Reproductive system and breast -Oth spec	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Reproductive system and breast disorders Testicular pain	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Cough	8.8% 12/136 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 21/136 • Number of events 27 • Adverse events were followed for 25 months and mortality was followed for 67 months.	16.8% 22/131 • Number of events 24 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.6% 13/136 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.	10.7% 14/131 • Number of events 16 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 17/136 • Number of events 20 • Adverse events were followed for 25 months and mortality was followed for 67 months.	9.2% 12/131 • Number of events 14 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 9 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.7% 5/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	2.2% 3/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.1% 7/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Sore throat	4.4% 6/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	7.6% 10/131 • Number of events 12 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Alopecia	1.5% 2/136 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.	8.4% 11/131 • Number of events 25 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.1% 4/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.9% 4/136 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Nail changes	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrm	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Pruritus	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	3.8% 5/131 • Number of events 5 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Purpura	1.5% 2/136 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.0% 19/136 • Number of events 26 • Adverse events were followed for 25 months and mortality was followed for 67 months.	13.7% 18/131 • Number of events 27 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	3.7% 5/136 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 67 months.	6.9% 9/131 • Number of events 21 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Skin ulceration	1.5% 2/136 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Surgical and medical procedures Surgical and medical proced - Oth spec	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Hematoma	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Hypertension	12.5% 17/136 • Number of events 26 • Adverse events were followed for 25 months and mortality was followed for 67 months.	13.0% 17/131 • Number of events 31 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Hypotension	14.7% 20/136 • Number of events 25 • Adverse events were followed for 25 months and mortality was followed for 67 months.	13.0% 17/131 • Number of events 22 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Peripheral ischemia	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.00% 0/131 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Phlebitis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Superficial thrombophlebitis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Thromboembolic event	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	2.3% 3/131 • Number of events 10 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Vascular disorders - Other, specify	0.74% 1/136 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.	1.5% 2/131 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 67 months.
Vascular disorders Vasculitis	0.00% 0/136 • Adverse events were followed for 25 months and mortality was followed for 67 months.	0.76% 1/131 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 67 months.

Additional Information

Geoffrey Uy

Siteman Cancer Center

Phone: 314-454-8304

Email: guy@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60