Trial Outcomes & Findings for Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia (NCT NCT03573024)

NCT ID: NCT03573024

Last Updated: 2026-08-07

Results Overview

The response rate will be measure by the European Leukemia Net definition (CRMRD-+CR+CRi+MLFS) will be used to determine number of patients responding to treatment out of all patients receiving treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Study start date to study end date, or death, whichever comes first, approximately 4 years

Results posted on

2026-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Azacitidine and Venetoclax Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azacitidine and Venetoclax n=36 Participants Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Age, Customized Age 18 or older	36 Participants n=36 Participants
Sex: Female, Male Female	20 Participants n=36 Participants
Sex: Female, Male Male	16 Participants n=36 Participants

PRIMARY outcome

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

The response rate will be measure by the European Leukemia Net definition (CRMRD-+CR+CRi+MLFS) will be used to determine number of patients responding to treatment out of all patients receiving treatment.

Outcome measures

Outcome measures
Measure	Azacitidine and Venetoclax n=36 Participants Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Response Rate, Measured by the European Leukemia Net Definition: (CRMRD-+CR+CRi+MLFS)	25 Participants

PRIMARY outcome

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Number of participants with new cases of Complete Remission, Complete Remission with Incomplete Blood Count Recovery, or Morphologic Leukemia Free State. This will be measured by multi-dimensional flow cytometry with a sensitivity to 0.1%.

Outcome measures

Outcome measures
Measure	Azacitidine and Venetoclax n=36 Participants Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Number of Participants That Achieved Minimal Residual Disease (MRD) Negative Responses	23 Participants

SECONDARY outcome

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Remission Duration will be defined as the length of time a patient does not display leukemic blasts or extramedullary disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Determined using Kaplan Meier survival analysis methods with 95% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study start date to study end date, or death, whichever comes first, approximately 4 years

Overall Survival will be defined as the time from administration of the initial doses until death from any cause. Determined using Kaplan Meier survival analysis methods with 95% confidence intervals.

Outcome measures

Outcome data not reported

Adverse Events

Azacitidine and Venetoclax

Serious events: 16 serious events

Other events: 36 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Azacitidine and Venetoclax n=36 participants at risk Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Gastrointestinal disorders Abdominal Pain	2.8% 1/36 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Anemia	2.8% 1/36 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Appendicitis	2.8% 1/36 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Blood and Lymphatic System Disorders - Other, Specify	5.6% 2/36 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	2.8% 1/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Hepatobiliary disorders Cholecystitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Creatinine Increased	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Febrile Neutropenia	19.4% 7/36 • Number of events 10 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Fever	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Gastritis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Hepatobiliary disorders Hepatic Hemorrhage	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Hypoxia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Infections and Infestations - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Intracranial hemorrhage	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Multi-Organ Failure	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic, and Mediastinal Disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Sepsis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Surgical and medical procedures Surgical and Medical Procedures - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Thromboembolic Event	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Tumor Lysis Syndrome	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events

Other adverse events

Other adverse events
Measure	Azacitidine and Venetoclax n=36 participants at risk Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished. Azacitidine: On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days. Venetoclax: Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
Gastrointestinal disorders Abdominal Distension	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Abdominal Pain	13.9% 5/36 • Number of events 6 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Acidosis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Activated partial thromboplastin time prolonged	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Acute Kidney Injury	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Alanine Aminotransferase Increased	16.7% 6/36 • Number of events 14 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Alkaline Phosphatase Increased	8.3% 3/36 • Number of events 7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Immune system disorders Allergic Reaction	2.8% 1/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Alopecia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Anemia	44.4% 16/36 • Number of events 36 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Anorectal Infection	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Anorexia	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Anxiety	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 3/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Aspartate Aminotransferase Increased	13.9% 5/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Aspiration	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Back Pain	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Bloating	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Blood and Lymphatic System Disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Blood Bilirubin Increased	11.1% 4/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Eye disorders Blurred Vision	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Bone Pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Bruising	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Burn	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Cardiac Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Catheter Related Infection	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Chills	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Chronic Kidney Disease	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Colitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Confusion	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Conjunctivitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Constipation	30.6% 11/36 • Number of events 11 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Cough	13.9% 5/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Creatinine Increased	8.3% 3/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Dehydration	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Delirium	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Depression	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Diarrhea	38.9% 14/36 • Number of events 20 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Dizziness	11.1% 4/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Dry Mouth	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Dry Skin	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Dysgeusia	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Reproductive system and breast disorders Dysmenorrhea	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Dyspepsia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Dysphagia	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 9/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Dysuria	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Edema Limbs	13.9% 5/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Encephalopathy	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Endocrine disorders Endocrine Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Enterocolitis Infectious	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Esophagitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Eye disorders Eye Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Fall	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Fatigue	25.0% 9/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Febrile Neutropenia	27.8% 10/36 • Number of events 14 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Fever	25.0% 9/36 • Number of events 12 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Fibrinogen Decreased	2.8% 1/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Flank Pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Flatulence	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Gastritis	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Gastroesophageal reflux disease	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Gastrointestinal Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders General Disorders and Administration Site Conditions - Other, Specify	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Gum Infection	2.8% 1/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Headache	27.8% 10/36 • Number of events 10 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Hematoma	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Hemorrhoidal Hemorrhage	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Hemorrhoids	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Hepatobiliary disorders Hepatobiliary Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Hiccups	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Hot Flashes	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypercalcemia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hyperglycemia	5.6% 2/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypermagnesemia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypernatremia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hyperphosphatemia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Hypertension	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hyperuricemia	8.3% 3/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypoalbuminemia	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypocalcemia	44.4% 16/36 • Number of events 29 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypokalemia	33.3% 12/36 • Number of events 19 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypomagnesemia	8.3% 3/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hyponatremia	11.1% 4/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypophosphatemia	19.4% 7/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Hypotension	22.2% 8/36 • Number of events 8 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Hypoxia	19.4% 7/36 • Number of events 8 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Ileus	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Infections and infestations - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Infusion Related Reaction	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations INR Increased	13.9% 5/36 • Number of events 13 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Insomnia	13.9% 5/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Intracranial Hemorrhage	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Investigations - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Lethargy	2.8% 1/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Lymphocyte Count Decreased	16.7% 6/36 • Number of events 41 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Malaise	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Reproductive system and breast disorders Menorrhagia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Metabolism and Nutrition Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Mucositis oral	22.2% 8/36 • Number of events 8 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Myalgia	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Myocarditis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Nail Loss	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Nausea	44.4% 16/36 • Number of events 19 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Neck Edema	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Neutrophil Count Decreased	33.3% 12/36 • Number of events 83 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Non-cardiac chest pain	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Oral Pain	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
General disorders Pain	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Pain in Extremity	13.9% 5/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Palpitations	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Papulopustular rash	5.6% 2/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Paresthesia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Paroxysmal atrial tachycardia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Pericardial Effusion	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Pericardial Tamponade	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Platelet Count Decreased	38.9% 14/36 • Number of events 83 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pleaural effusions	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Hepatobiliary disorders Portal Vein Thrombosis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Pruritus	13.9% 5/36 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Psychiatric disorders Psychiatric Disorders - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	8.3% 3/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Rash Acneiform	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Rash Maculo-papular	22.2% 8/36 • Number of events 10 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Sepsis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Sinus Bradycardia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Sinus Tachycardia	16.7% 6/36 • Number of events 7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Skin Infection	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Social circumstances Social Circumstances - Other, Specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Somnolence	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Sore Throat	22.2% 8/36 • Number of events 9 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Stomach pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Superficial thrombophlebitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Nervous system disorders Syncope	5.6% 2/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Thromboembolic Event	8.3% 3/36 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Thrush	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Typhlitis	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.6% 2/36 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Urinary frequency	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Urinary tract infection	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Renal and urinary disorders Urinary tract pain	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Urticaria	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Infections and infestations Vaginal Infection	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Vascular disorders Vascular Disorders - Other, specify	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Cardiac disorders Ventricular tachycardia	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Vomiting	36.1% 13/36 • Number of events 18 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations Weight loss	11.1% 4/36 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Investigations White blood cell decreased	50.0% 18/36 • Number of events 86 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Injury, poisoning and procedural complications Wound Complication	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Gastrointestinal Disorders	2.8% 1/36 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle (28 days) completed. 1.All-Cause Mortality 2.Serious Adverse Events 3.Other (Not Including Serious) Adverse Events

Additional Information

Dr. Daniel Pollyea

University of Colorado Anschutz

Phone: 3037249562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place