Trial Outcomes & Findings for Split-Dose R-CHOP for Older Adults With DLBCL (NCT NCT03943901)

Last Updated: 2026-01-29

Results Overview

Simon 2-stage design with complete response (CR) rate at the end of treatment as our primary outcome. 40% is an unacceptable boundary for complete response rate and 60% as an acceptable complete response rate. CR at the end of treatment, will be estimated as the observed proportion and presented with a 95% Wilson confidence interval.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

up to 6 months

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Split Dose R-CHOP Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Overall Study STARTED	27
Overall Study On Treatment	26
Overall Study Off Treatment	26
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Split Dose R-CHOP Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Overall Study On Follow Up	12
Overall Study deemed not eligible prior to starting treatment	1

Baseline Characteristics

Split-Dose R-CHOP for Older Adults With DLBCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Split Dose R-CHOP n=27 Participants Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Age, Customized 70-79 years	13 Participants n=41 Participants
Age, Customized 80-89 years	14 Participants n=41 Participants
Sex: Female, Male Female	12 Participants n=41 Participants
Sex: Female, Male Male	15 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Race (NIH/OMB) White	27 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	27 participants n=41 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: number of participants who started treatment

Outcome measures

Outcome measures
Measure	Split Dose R-CHOP n=26 Participants Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.	Grade 3 Severe symptoms	Grade 4 Life-threatening symptoms	Grade 5 Fatal
Complete Response Rate (CR)	17 Participants	—	—	—

SECONDARY outcome

Timeframe: up to 2 years 6 months

PFS measures survival without relapse/progression or death starting from study enrollment. Relapse or progression of disease and death will be considered as events; subjects who survive without recurrence or progression will be censored at last contact. PFS will be estimated using the Kaplan Meier estimate and presented with graphically with pointwise 95% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years 6 months

OS measures time to death starting from study enrollment. Death from any cause will be considered an event; surviving subjects will be censored at time of last follow-up. OS will be estimated using the Kaplan-Meier estimate and presented with graphically with pointwise 95% confidence intervals. Exploratory Cox proportional hazards regression will be used to evaluate the effect of baseline covariates on PFS and OS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up 6 months

The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment. The proportion of subjects experiencing a Serious Adverse Event (SAE) will be reported with 95% confidence intervals overall. Toxicity will be monitored using the formal boundary described in the protocol.

Outcome measures

Outcome measures
Measure	Split Dose R-CHOP n=26 Participants Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.	Grade 3 Severe symptoms	Grade 4 Life-threatening symptoms	Grade 5 Fatal
Incidence of Treatment Emergent Serious Adverse Events	0.346 proportion of participants	—	—	—

SECONDARY outcome

Timeframe: up 6 months

The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment.

Outcome measures

Outcome measures
Measure	Split Dose R-CHOP n=2 serious adverse events Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.	Grade 3 n=30 serious adverse events Severe symptoms	Grade 4 n=7 serious adverse events Life-threatening symptoms	Grade 5 n=3 serious adverse events Fatal
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Renal and urinary disorders	0 serious adverse events	1 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System General disorders and administration site conditions	0 serious adverse events	5 serious adverse events	0 serious adverse events	1 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Hepatobiliary disorders	1 serious adverse events	1 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Infections and infestations	0 serious adverse events	8 serious adverse events	1 serious adverse events	2 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Injury, poisoning and procedural complications	0 serious adverse events	3 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Metabolism and nutrition disorders	1 serious adverse events	1 serious adverse events	1 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Nervous system disorders	0 serious adverse events	2 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Skin and subcutaneous tissue disorders	0 serious adverse events	2 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Vascular disorders	0 serious adverse events	1 serious adverse events	0 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Blood and lymphatic system disorders	0 serious adverse events	2 serious adverse events	1 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Cardiac system disorders	0 serious adverse events	1 serious adverse events	3 serious adverse events	0 serious adverse events
Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System Gastrointestinal disorders	0 serious adverse events	3 serious adverse events	1 serious adverse events	0 serious adverse events

SECONDARY outcome

Timeframe: up to 2 years 6 months

Cancer-specific geriatric assessment prior to, during, and after completion of chemotherapy treatments to evaluate for changes in physical function, mental health, cognition, and other relevant geriatric specific outcomes. The geriatric assessment measures will be summarized descriptively at each measurement time-point using appropriate descriptive statistics such as frequencies and percentages with standard errors for categorical variables, mean with standard error or median with quartiles for continuous variables.

Outcome measures

Outcome data not reported

Adverse Events

Split Dose R-CHOP

Serious events: 9 serious events

Other events: 27 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Split Dose R-CHOP n=27 participants at risk；n=26 participants at risk Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Blood and lymphatic system disorders Febrile neutropenia	11.5% 3/26 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Cardiac disorder, unknown	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Atrial fibrillation	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Myocarditis	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Heart failure	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Esophageal perforation	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Multi-organ failure	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Fatigue	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Fluid Volume Overload	7.7% 2/26 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Hepatobiliary disorders Cholecystitis	7.7% 2/26 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations COVID-19	11.5% 3/26 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Lung infection	11.5% 3/26 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Sepsis	7.7% 2/26 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Urinary tract infection	7.7% 2/26 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Fall	7.7% 2/26 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperkalemia	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypercalcemia	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Dehydration	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Syncope	7.7% 2/26 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Acute kidney injury	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders LE blisters	3.8% 1/26 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Hematoma	3.8% 1/26 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).

Other adverse events

Other adverse events
Measure	Split Dose R-CHOP n=27 participants at risk；n=26 participants at risk Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Eye disorders Eye pain	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Abdominal pain	22.2% 6/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Activated partial thromboplastin time prolonged	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Acute kidney injury	14.8% 4/27 • Number of events 8 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Alanine aminotransferase increased	22.2% 6/27 • Number of events 13 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Alkaline phosphatase increased	37.0% 10/27 • Number of events 28 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Immune system disorders Allergic reaction	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Alopecia	18.5% 5/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Blood and lymphatic system disorders Anemia	70.4% 19/27 • Number of events 66 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Anorexia	25.9% 7/27 • Number of events 9 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Anxiety	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Arthritis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Arthritis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Aspartate aminotransferase increased	33.3% 9/27 • Number of events 16 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Atrial fibrillation	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Atrial flutter	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Back pain	14.8% 4/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Bloating	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Blood bicarbonate decreased	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Blood bilirubin increased	18.5% 5/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low creatinine	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Blood lactate dehydrogenase increased	40.7% 11/27 • Number of events 25 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Blurred vision	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Bone pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Bruising	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Buttock pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Cardiac troponin I increased	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Chills	14.8% 4/27 • Number of events 8 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Hepatobiliary disorders Cholecystitis	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Cholesterol high	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Chronic kidney disease	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Colitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Concentration impairment	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Confusion	7.4% 2/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Conjunctivitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Constipation	48.1% 13/27 • Number of events 18 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Cough	18.5% 5/27 • Number of events 7 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Creatinine increased	22.2% 6/27 • Number of events 16 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Dehydration	14.8% 4/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Delirium	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Dental caries	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Depression	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Diarrhea	18.5% 5/27 • Number of events 12 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Dizziness	37.0% 10/27 • Number of events 17 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Dry eye	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Dry mouth	22.2% 6/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Dry skin	18.5% 5/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Dysgeusia	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Dyspepsia	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Dysphagia	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Dyspnea	40.7% 11/27 • Number of events 17 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Dysuria	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Ear and labyrinth disorders Ear pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Eczema	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Edema limbs	51.9% 14/27 • Number of events 25 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Blood and lymphatic system disorders Eosinophilia	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Esophageal perforation	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Keratitis sicca	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Pseudophakia	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Eye infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Fall	22.2% 6/27 • Number of events 10 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Fatigue	55.6% 15/27 • Number of events 29 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Blood and lymphatic system disorders Febrile neutropenia	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Fecal incontinence	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Fever	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Flank pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Flatulence	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Flushing	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Gait disturbance	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Gastritis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Gastroesophageal reflux disease	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Indigestion	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Sore on lip	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Hematochezia	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders R sided maxillary pressure	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Numbness of left foot and hand	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Stiffness in legs (in AM)	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Fluid Volume Overload	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Swollen Thumb	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.8% 4/27 • Number of events 7 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations GGT increased	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Glaucoma	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Headache	22.2% 6/27 • Number of events 13 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Heart failure	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Hematoma	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Hematuria	7.4% 2/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Hepatobiliary disorders Elevated LFTs	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Hiccups	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Hoarseness	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Hot flashes	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypercalcemia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperglycemia	25.9% 7/27 • Number of events 13 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Hyperhidrosis	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperkalemia	14.8% 4/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperlipidemia	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypermagnesemia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperphosphatemia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Hypertension	37.0% 10/27 • Number of events 37 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyperuricemia	14.8% 4/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypoalbuminemia	55.6% 15/27 • Number of events 39 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypocalcemia	33.3% 9/27 • Number of events 35 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypoglycemia	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypokalemia	40.7% 11/27 • Number of events 31 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypomagnesemia	25.9% 7/27 • Number of events 15 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hyponatremia	33.3% 9/27 • Number of events 28 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Metabolism and nutrition disorders Hypophosphatemia	37.0% 10/27 • Number of events 18 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Hypotension	22.2% 6/27 • Number of events 11 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Hypoxia	7.4% 2/27 • Number of events 8 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations COVID-19	14.8% 4/27 • Number of events 7 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Mild cold	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low uric acid	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Bacteruria (E. Coli)	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Pyelonephritis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Infusion related reaction	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Small cut on leg	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Head pain (d/t syncope)	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Wound	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Injury, poisoning and procedural complications Deep tissue Injury	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Insomnia	18.5% 5/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High chloride	7.4% 2/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low red count	3.7% 1/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low hematocrit	3.7% 1/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low monocytes	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low MCH	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High RDW	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High neutrophils	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High monocytes	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low globulin	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low total protein	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High absolute immature granulocytes	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations High myelocytes	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Low anion gap	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Psychiatric disorders Irritability	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Lethargy	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Blood and lymphatic system disorders Leukocytosis	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Lung infection	14.8% 4/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Lymphocyte count decreased	77.8% 21/27 • Number of events 103 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Malaise	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Memory impairment	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Mucositis oral	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Multi-organ failure	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Muscle cramp	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Bleeding Toe	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders stiffness	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Myalgia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Myocarditis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Nail changes	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Nail infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Nail loss	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Nausea	25.9% 7/27 • Number of events 14 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Neck pain	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Neutrophil count decreased	44.4% 12/27 • Number of events 49 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
General disorders Non-cardiac chest pain	22.2% 6/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Oral hemorrhage	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Oral pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 6/27 • Number of events 10 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Paresthesia	18.5% 5/27 • Number of events 10 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Paronychia	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Peripheral motor neuropathy	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Peripheral sensory neuropathy	37.0% 10/27 • Number of events 16 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Phlebitis	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Platelet count decreased	51.9% 14/27 • Number of events 63 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.7% 1/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Productive cough	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Prostate infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Proteinuria	7.4% 2/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Pruritus	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Rash maculo-papular	14.8% 4/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Scalp pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Sepsis	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Sinus bradycardia	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Sinus pain	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Cardiac disorders Sinus tachycardia	11.1% 3/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Sinusitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Scratched by dog	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Small flat blister-like spot on thigh	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders wound buttocks & left foot	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders bleeding wound on foot	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders rash- macules, erythema	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Broad actinic keratoses	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Stasis dermatitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Notalgia paresthetica	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Skin irritation	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders LE Blisters	3.7% 1/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Purpura	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Skin infection	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Sore throat	18.5% 5/27 • Number of events 5 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Superficial thrombophlebitis	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Syncope	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Vascular disorders Thromboembolic event	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Toothache	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Nervous system disorders Tremor	11.1% 3/27 • Number of events 3 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Urinary frequency	22.2% 6/27 • Number of events 6 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Urinary incontinence	22.2% 6/27 • Number of events 7 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Urinary retention	11.1% 3/27 • Number of events 4 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Urinary tract infection	25.9% 7/27 • Number of events 9 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Renal and urinary disorders Urinary urgency	7.4% 2/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Skin and subcutaneous tissue disorders Urticaria	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Reproductive system and breast disorders Vaginal dryness	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Vaginal infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Vision decreased	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Gastrointestinal disorders Vomiting	22.2% 6/27 • Number of events 16 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Vulval infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Eye disorders Watering eyes	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Weight gain	7.4% 2/27 • Number of events 8 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations Weight loss	22.2% 6/27 • Number of events 14 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 1/27 • Number of events 2 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Investigations White blood cell decreased	51.9% 14/27 • Number of events 58 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).
Infections and infestations Wound infection	3.7% 1/27 • Number of events 1 • Data collected up to approximately 6 months All-cause mortality is reported for all participants enrolled (N=27). Per protocol section 7.4.4: The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment (N=26). Per protocol section 8.3: Adverse events will be recorded from the beginning of informed consent until 2 weeks after completion of the last cycle of chemotherapy (N=27).

Additional Information

Christopher Fletcher, MD

UW School of Medicine and Public Health

Phone: (608) 263-3135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place