Trial Outcomes & Findings for Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (NCT NCT04736472)

Last Updated: 2025-06-06

Results Overview

The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.

Recruitment status

COMPLETED

Study phase

Target enrollment

552 participants

Primary outcome timeframe

14 days

Results posted on

2025-06-06

Participant Flow

Of the 552 enrolled participants, 531 were eligible to begin study procedures.

Participant milestones

Participant milestones
Measure	Prospective Cohort Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Confirmatory Cohort Enrollees were given DPYD and UGT1A1 testing after starting chemotherapy at physician's request	BioBank Control Enrollees with biobank samples were tested for DPYD and UGT1A1 variants, and retrospectively chart reviewed for outcomes
Overall Study STARTED	276	20	235
Overall Study Completed PGx Testing	268	20	231
Overall Study Completed Relevant Chemotherapy	225	20	229
Overall Study COMPLETED	225	20	229
Overall Study NOT COMPLETED	51	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Prospective Cohort Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	BioBank Control Enrollees with biobank samples were tested for DPYD and UGT1A1 variants, and retrospectively chart reviewed for outcomes
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Protocol Violation	48	6

Baseline Characteristics

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Cohort n=276 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Confirmatory Cohort n=20 Participants Enrollees were given DPYD and UGT1A1 testing after starting chemotherapy at physician's request	BioBank Cohort n=235 Participants Enrollees with biobank samples were tested for DPYD and UGT1A1 variants, and retrospectively chart reviewed for outcomes	Total n=531 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=99 Participants	11 Participants n=107 Participants	149 Participants n=206 Participants	322 Participants n=7 Participants
Age, Categorical >=65 years	114 Participants n=99 Participants	9 Participants n=107 Participants	86 Participants n=206 Participants	209 Participants n=7 Participants
Sex: Female, Male Female	125 Participants n=99 Participants	12 Participants n=107 Participants	114 Participants n=206 Participants	251 Participants n=7 Participants
Sex: Female, Male Male	151 Participants n=99 Participants	8 Participants n=107 Participants	121 Participants n=206 Participants	280 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	10 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	265 Participants n=99 Participants	19 Participants n=107 Participants	0 Participants n=206 Participants	284 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	1 Participants n=107 Participants	234 Participants n=206 Participants	237 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	11 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	14 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	50 Participants n=99 Participants	0 Participants n=107 Participants	38 Participants n=206 Participants	88 Participants n=7 Participants
Race (NIH/OMB) White	205 Participants n=99 Participants	19 Participants n=107 Participants	189 Participants n=206 Participants	413 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants	16 Participants n=7 Participants
Region of Enrollment United States	276 participants n=99 Participants	20 participants n=107 Participants	235 participants n=206 Participants	531 participants n=7 Participants
ECOG at Enrollment 0	151 Participants n=99 Participants	12 Participants n=107 Participants	102 Participants n=206 Participants	265 Participants n=7 Participants
ECOG at Enrollment 1	89 Participants n=99 Participants	6 Participants n=107 Participants	109 Participants n=206 Participants	204 Participants n=7 Participants
ECOG at Enrollment 2	20 Participants n=99 Participants	1 Participants n=107 Participants	21 Participants n=206 Participants	42 Participants n=7 Participants
ECOG at Enrollment 3	8 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	12 Participants n=7 Participants
ECOG at Enrollment NA	8 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	8 Participants n=7 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Number and percentage of participants with both PGx test results and who began a qualifying chemotherapy. The BioBank Cohort and Confirmatory Cohort are not included in this measure as their PGx testing was intentionally ordered after their first dose of chemotherapy, therefore how many results were returned prior to first dose was not applicable.

The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.

Outcome measures

Outcome measures
Measure	Prospective Cohort n=225 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Prospective Cohort, Non-DGI Group Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy, and were not found to have a drug gene interaction (DGI) between their genotype and planned chemotherapy	BioBank Cohort, DGI Group Enrollees were tested for DPYD and UGT1A1 variants, and found to have a drug gene interaction (DGI) between their genotype and chemotherapy that would have been actionable, and retrospectively chart reviewed for outcomes	BioBank Cohort, Normal Metabolizers Group Enrollees were tested for DPYD and UGT1A1 variants, and were not found to have a drug gene interaction (DGI) between their genotype and chemotherapy, and retrospectively chart reviewed for outcomes	Confirmatory Cohort Enrollees were tested for DPYD and UGT1A1 variants after starting chemotherapy at physician request as a courtesy.
Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose PGx Result Returned before Chemotherapy	130 Participants	—	—	—	—
Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose PGx Result Returned After Chemotherapy	95 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 14 days

Population: Number and percentage of participants with an actionable genetic variant also receiving an interacting chemotherapy (DPYD Poor and Intermediate Metabolizers receiving fluoropyrimidine and UGT1A1 Poor Metabolizers receiving irinotecan). The BioBank Cohort and Confirmatory Cohort are not included in this measure as their PGx testing was intentionally ordered after their first dose of chemotherapy, therefore modifying their chemotherapy to match PGx results was not applicable.

The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.

Outcome measures

Outcome measures
Measure	Prospective Cohort n=16 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Prospective Cohort, Non-DGI Group Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy, and were not found to have a drug gene interaction (DGI) between their genotype and planned chemotherapy	BioBank Cohort, DGI Group Enrollees were tested for DPYD and UGT1A1 variants, and found to have a drug gene interaction (DGI) between their genotype and chemotherapy that would have been actionable, and retrospectively chart reviewed for outcomes	BioBank Cohort, Normal Metabolizers Group Enrollees were tested for DPYD and UGT1A1 variants, and were not found to have a drug gene interaction (DGI) between their genotype and chemotherapy, and retrospectively chart reviewed for outcomes	Confirmatory Cohort Enrollees were tested for DPYD and UGT1A1 variants after starting chemotherapy at physician request as a courtesy.
Fidelity: Level of Agreement With Dose Recommendations Number and percent of participants with PGx test results returned before chemotherapy initiation	11 Participants	—	—	—	—
Fidelity: Level of Agreement With Dose Recommendations Number and percent of participants with DPYD dose mods in agreement to genotype-recommendations	6 Participants	—	—	—	—
Fidelity: Level of Agreement With Dose Recommendations Number and percent of participants with UGT1A1 dose mods in agreement to genotype-recommendations	5 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 14 days

Population: In order to calculate the penetrance of the intervention, as this was an implementation trial, it is necessary to consider the total number of patients who would have been eligible for recruitment. This includes both the prospective arms, as well as individuals in participating clinics during the study timeframe who were not approached for consent due to personnel and screening limitations.

The number and percentage of participants with pharmacogenetic tests ordered compared to the number of patients eligible for testing at participating sites during the study timeframe

Outcome measures

Outcome measures
Measure	Prospective Cohort n=1566 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Prospective Cohort, Non-DGI Group Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy, and were not found to have a drug gene interaction (DGI) between their genotype and planned chemotherapy	BioBank Cohort, DGI Group Enrollees were tested for DPYD and UGT1A1 variants, and found to have a drug gene interaction (DGI) between their genotype and chemotherapy that would have been actionable, and retrospectively chart reviewed for outcomes	BioBank Cohort, Normal Metabolizers Group Enrollees were tested for DPYD and UGT1A1 variants, and were not found to have a drug gene interaction (DGI) between their genotype and chemotherapy, and retrospectively chart reviewed for outcomes	Confirmatory Cohort Enrollees were tested for DPYD and UGT1A1 variants after starting chemotherapy at physician request as a courtesy.
Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers	288 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Prospective and BioBank Cohorts are broken out into DGI and Non-DGI groups to compare participant outcomes by genotype.

Percentage of patients experiencing a severe TRAE (an event requiring hospitalization, emergency room visits, or oncology evaluation center). Severe TRAEs were one of the outcomes measured by the study.

Outcome measures

Outcome measures
Measure	Prospective Cohort n=16 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Prospective Cohort, Non-DGI Group n=209 Participants Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy, and were not found to have a drug gene interaction (DGI) between their genotype and planned chemotherapy	BioBank Cohort, DGI Group n=17 Participants Enrollees were tested for DPYD and UGT1A1 variants, and found to have a drug gene interaction (DGI) between their genotype and chemotherapy that would have been actionable, and retrospectively chart reviewed for outcomes	BioBank Cohort, Normal Metabolizers Group n=212 Participants Enrollees were tested for DPYD and UGT1A1 variants, and were not found to have a drug gene interaction (DGI) between their genotype and chemotherapy, and retrospectively chart reviewed for outcomes	Confirmatory Cohort n=20 Participants Enrollees were tested for DPYD and UGT1A1 variants after starting chemotherapy at physician request as a courtesy.
Severe Treatment Related Adverse Events (TRAE) Treatment Discontinuation	5 Participants	49 Participants	8 Participants	60 Participants	8 Participants
Severe Treatment Related Adverse Events (TRAE) Severe TRAEs	6 Participants	63 Participants	10 Participants	66 Participants	10 Participants
Severe Treatment Related Adverse Events (TRAE) Treatment Modifications	6 Participants	107 Participants	13 Participants	108 Participants	12 Participants

Adverse Events

Prospective Cohort

Serious events: 69 serious events

Other events: 214 other events

Deaths: 35 deaths

Confirmatory Cohort

Serious events: 10 serious events

Other events: 20 other events

Deaths: 3 deaths

BioBank Cohort

Serious events: 76 serious events

Other events: 140 other events

Deaths: 47 deaths

Serious adverse events

Serious adverse events
Measure	Prospective Cohort n=225 participants at risk Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Confirmatory Cohort n=20 participants at risk Enrollees were given DPYD and UGT1A1 testing after starting chemotherapy at physician's request	BioBank Cohort n=229 participants at risk Enrollees with biobank samples were tested for DPYD and UGT1A1 variants, and retrospectively chart reviewed for outcomes
Blood and lymphatic system disorders Neutropenia	3.6% 8/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	1.7% 4/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Diarrhea	5.8% 13/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	20.0% 4/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	7.0% 16/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Vomiting	6.7% 15/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	10.0% 2/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	8.3% 19/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
General disorders Weakness	4.4% 10/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Infections and infestations Sepsis	3.1% 7/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	4.8% 11/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
General disorders Fever	5.8% 13/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.44% 1/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Blood and lymphatic system disorders Thrombosis	4.4% 10/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
General disorders Pain	7.1% 16/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	10.0% 2/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	2.2% 5/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Metabolism and nutrition disorders Dehydration	1.8% 4/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
General disorders Other	7.6% 17/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	15.0% 3/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	19.7% 45/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Nausea	6.2% 14/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	10.0% 2/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	7.0% 16/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.

Other adverse events

Other adverse events
Measure	Prospective Cohort n=225 participants at risk Enrollees were given DPYD and UGT1A1 testing before starting chemotherapy	Confirmatory Cohort n=20 participants at risk Enrollees were given DPYD and UGT1A1 testing after starting chemotherapy at physician's request	BioBank Cohort n=229 participants at risk Enrollees with biobank samples were tested for DPYD and UGT1A1 variants, and retrospectively chart reviewed for outcomes
Blood and lymphatic system disorders Neutropenia	43.6% 98/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	65.0% 13/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	20.5% 47/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Blood and lymphatic system disorders Thrombocytopenia	40.4% 91/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	40.0% 8/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	9.6% 22/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Blood and lymphatic system disorders Anemia	64.4% 145/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	75.0% 15/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	6.1% 14/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Diarrhea	51.1% 115/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	55.0% 11/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	17.5% 40/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Nausea	62.2% 140/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	75.0% 15/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	16.2% 37/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Vomiting	20.0% 45/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	30.0% 6/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	9.6% 22/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Gastrointestinal disorders Mucositis	15.6% 35/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	15.0% 3/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	3.9% 9/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Skin and subcutaneous tissue disorders Hand Foot Syndrome	12.9% 29/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	7.4% 17/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Cardiac disorders Heart Palpitations	10.7% 24/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.9% 29/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Nervous system disorders Peripheral Neuropathy	0.00% 0/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.00% 0/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	14.4% 33/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Cardiac disorders Chest Pain	6.2% 14/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	5.0% 1/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	2.2% 5/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.
Blood and lymphatic system disorders Febrile Neutropenia	4.0% 9/225 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	10.0% 2/20 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.	0.44% 1/229 • Adverse event data was collected during the first six cycles of chemotherapy, <6 months. Severe adverse events were defined as any related event requiring hospitalization, emergency room visits, oncology evaluation center care, or death. Other adverse events are all other adverse events that were collected that did not meet the serious criteria. Events were primarily assessed through medical records review.

Additional Information

Sony Tuteja, PI

University of Pennsylvania

Phone: 215-573-7834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place