Trial Outcomes & Findings for Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma (NCT NCT00585078)

Last Updated: 2017-04-10

Results Overview

Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.

Results posted on

2017-04-10

Participant Flow

Participants were enrolled from May 2004 to March 2010.

Participant milestones

Participant milestones
Measure	CAPOX Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Overall Study STARTED	40
Overall Study Treated	37
Overall Study Toxicity Evaluable	36
Overall Study Response Evaluable	24
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	CAPOX Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Overall Study Withdrawal by Subject	4
Overall Study Poor performance status	1
Overall Study Disease Progression	24
Overall Study Adverse Event	10
Overall Study Death	1

Baseline Characteristics

Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAPOX n=40 Participants Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Stage Locally Advanced	2 Participants n=5 Participants
Stage Metastatic	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.

Population: The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.

Outcome measures

Outcome measures
Measure	CAPOX n=24 Participants Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Response Rate	.125 proportion of participants Interval 0.035 to 0.201

SECONDARY outcome

Population: The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.

Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.

Outcome measures

Outcome measures
Measure	CAPOX n=24 Participants Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Best Response Complete Response	0 participants
Best Response Partial Response	3 participants
Best Response Stable Disease	13 participants
Best Response Progressive Disease	8 participants

SECONDARY outcome

Timeframe: Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.

Population: The analysis dataset is comprised of treated participants.

Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.

Outcome measures

Outcome measures
Measure	CAPOX n=37 Participants Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Overall Survival	7.4 months Interval 4.8 to 12.2

SECONDARY outcome

Timeframe: Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.

Population: The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure	CAPOX n=24 Participants Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Progression-Free Survival	3.8 months Interval 1.3 to 6.2

Adverse Events

CAPOX

Serious events: 18 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CAPOX n=36 participants at risk Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Blood and lymphatic system disorders Hemoglobin	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Diarrhea w/o prior colostomy	13.9% 5/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Nausea	16.7% 6/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Vomiting	11.1% 4/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Abdomen, pain	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Fatigue	19.4% 7/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Weight loss	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Metabolic/Laboratory-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Anorexia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Dehydration	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hypocalcemia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hyperkalemia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Neuropathy-sensory	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Psychiatric disorders Confusion	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Hand-foot reaction	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.

Other adverse events

Other adverse events
Measure	CAPOX n=36 participants at risk Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Blood and lymphatic system disorders Hemoglobin	30.6% 11/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Blood and lymphatic system disorders Hematologic-other	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Cardiac disorders Cardiac-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Ear and labyrinth disorders Hearing-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Eye disorders Vision-blurred	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Eye disorders Tearing	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Eye disorders Ocular-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Colitis	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Constipation	19.4% 7/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Diarrhea w/o prior colostomy	22.2% 8/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Dry mouth	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Esophagitis	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Flatulence	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Dyspepsia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	13.9% 5/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Nausea	52.8% 19/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Salivary	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Vomiting	41.7% 15/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders GI-other	25.0% 9/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Gastrointestinal disorders Abdomen, pain	11.1% 4/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Fatigue	52.8% 19/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Fever w/o neutropenia	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Rigors/chills	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Constitutional, other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
General disorders Pain-other	19.4% 7/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Infections and infestations Infection-other	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Leukocytes	13.9% 5/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Lymphopenia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Neutrophils	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Platelets	19.4% 7/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Weight loss	16.7% 6/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations INR	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations PTT	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Coagulation-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Alkaline phosphatase	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations ALT, SGPT	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations AST, SGOT	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Lipase	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Investigations Metabolic/Laboratory-other	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Anorexia	41.7% 15/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Dehydration	13.9% 5/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hypoalbuminemia	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hyperglycemia	11.1% 4/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hypomagnesemia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hypophosphatemia	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Metabolism and nutrition disorders Hyponatremia	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Taste disturbance	11.1% 4/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Dizziness	8.3% 3/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Neuropathy CN I smell	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Neuropathy-motor	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Neuropathy-sensory	58.3% 21/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Tremor	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Neurologic-other	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Nervous system disorders Head/headache	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Psychiatric disorders Insomnia	5.6% 2/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Psychiatric disorders Depression	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Renal and urinary disorders Incontinence urinary	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Dry skin	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Hypopigmentation	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Nail changes	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Pruritus/itching	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Rash/desquamation	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Hand-foot reaction	22.2% 8/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Skin and subcutaneous tissue disorders Skin-other	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.
Vascular disorders Hot flashes	2.8% 1/36 • Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX. Maximum grade toxicity by type was first calculated including only adverse events with treatment-attribution of possibly, probably or definitely related to CAPOX. Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3.The analysis dataset is comprised of all participants who started CAPOX and reported any toxicity data (toxicity evaluable). One participant was missing toxicity data.

Additional Information

Rebecca Miksad MD MPH

Beth Israel Deaconess Medical Center Beth Israel Deaconess

Phone: 617.667.2100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place