Trial Outcomes & Findings for Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity (NCT NCT02124902)

Last Updated: 2022-11-07

Results Overview

-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity or radiographic evidence of progression and then receives alternative treatment. * The patient discontinues study treatment, refuses surgery, or is unable to undergo surgery due to a co-morbid condition. Thus, any patient who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pCR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)

Results posted on

2022-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Overall Study STARTED	123	25
Overall Study COMPLETED	106	19
Overall Study NOT COMPLETED	17	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Overall Study Adverse Event	7	2
Overall Study Went to alternative treatment	4	0
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	2	0
Overall Study Not eligible	1	0
Overall Study Did not receive carboplatin in cycle 6	1	3

Baseline Characteristics

Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin n=123 Participants Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin n=25 Participants Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.	Total n=148 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	57 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	25 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	16 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	1 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	89 Participants n=5 Participants	22 Participants n=7 Participants	111 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants	25 participants n=7 Participants	148 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)

Population: 17 participants from Washington University were not evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin n=106 Participants Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin n=25 Participants Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Pathological Complete Response (pCR) Rate	47 Participants	11 Participants

Adverse Events

Washington University: Neoadjuvant Docetaxel and Carboplatin

Serious events: 21 serious events

Other events: 123 other events

Deaths: 9 deaths

Baylor: Neoadjuvant Docetaxel and Carboplatin

Serious events: 3 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Foluso Ademuyiwa, M.D., MPH

Washington University School of Medicine

Phone: 314-362-7201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin n=123 participants at risk Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin n=25 participants at risk Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Blood and lymphatic system disorders Anemia	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Blood and lymphatic system disorders Febrile neutropenia	4.9% 6/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	4.0% 1/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Cardiac disorders Atrial fibrillation	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Cardiac disorders Sinus tachycardia	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Abdominal pain	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Colitis	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	4.0% 1/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Constipation	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Diarrhea	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Diverticulitis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Gastritis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Nausea	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Oral thrush	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Vomiting	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
General disorders Fever	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
General disorders Pain	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
General disorders Pain in extremity	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Infections and infestations Pharyngitis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Infections and infestations Rash pustular	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Infections and infestations Skin infection	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Infections and infestations Urinary tract infection	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Investigations Neutrophil count decreased	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Investigations Platelet count decreased	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Investigations White blood cell decreased	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Metabolism and nutrition disorders Dehydration	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Metabolism and nutrition disorders Hyponatremia	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Metabolism and nutrition disorders Lactic acidosis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Metabolism and nutrition disorders Protein calorie malnutrition	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Psychiatric disorders Confusion	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Psychiatric disorders Suicide attempt	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Renal and urinary disorders Acute cystitis without gross hematuria	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Renal and urinary disorders Acute kidney injury	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Renal and urinary disorders Proteinuria	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Vascular disorders Thromboembolic event	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Ear and labyrinth disorders Vertigo	0.00% 0/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	4.0% 1/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.

Other adverse events
Measure	Washington University: Neoadjuvant Docetaxel and Carboplatin n=123 participants at risk Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.	Baylor: Neoadjuvant Docetaxel and Carboplatin n=25 participants at risk Docetaxel will be administered intravenously at a dose of 75mg/m\^2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Blood and lymphatic system disorders Anemia	87.8% 108/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	16.0% 4/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Blood and lymphatic system disorders Febrile neutropenia	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Cardiac disorders Non-cardiac chest pain	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Cardiac disorders Sinus tachycardia	3.3% 4/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Cardiac disorders Supraventricular tachycardia	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Ear and labyrinth disorders Ear pain	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Ear and labyrinth disorders Tinnitus	3.3% 4/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Ear and labyrinth disorders Vertigo	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Blurred vision	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Dacryostenosis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Dry eye	4.1% 5/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Epiphora	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Eye stye	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Eye twitching	2.4% 3/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Itchy eyes	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Viral conjunctivitis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Eye disorders Watering eyes	14.6% 18/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Abdominal pain	11.4% 14/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Anal fistula	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Bloating	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Blood in stool	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Colitis	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Colonic fistula	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Constipation	52.0% 64/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Diarrhea	51.2% 63/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	16.0% 4/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Diverticulitis	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Dry mouth	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Dysgeusia	3.3% 4/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Dyspepsia	36.6% 45/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Dysphagia	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Esophageal spasms	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Flatulence	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Gastroesophageal reflux disease	4.9% 6/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Mucositis oral	39.0% 48/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	4.0% 1/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Nausea	65.9% 81/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Oral dysesthesia	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Rectal hemorrhage	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Stomach pain	1.6% 2/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.
Gastrointestinal disorders Tender gums	0.81% 1/123 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.	0.00% 0/25 • Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.