Trial Outcomes & Findings for Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer (NCT NCT02921256)

Last Updated: 2025-12-04

Results Overview

A linear regression model that controls for the stratification factors (cT-stage and cN-stage) will be used. Mean NAR scores along with standard errors and confidence intervals will be reported by treatment. The NAR score ranges from zero to 100 with lower values corresponding to better prognosis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

363 participants

Primary outcome timeframe

Baseline to up to 3 years

Results posted on

2025-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (mFOLFOX6, RT, Capecitabine) Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II are described as Arm Ia and participants assigned to Arm I concurrently with Arm III are described as Arm Ib. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab: Given IV
Arm 1a v. Arm II STARTED	88	90	0
Arm 1a v. Arm II COMPLETED	72	57	0
Arm 1a v. Arm II NOT COMPLETED	16	33	0
Arm Ib v Arm III STARTED	95	0	90
Arm Ib v Arm III COMPLETED	71	0	75
Arm Ib v Arm III NOT COMPLETED	24	0	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (mFOLFOX6, RT, Capecitabine) Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II are described as Arm Ia and participants assigned to Arm I concurrently with Arm III are described as Arm Ib. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab: Given IV
Arm 1a v. Arm II Adverse Event	6	15	0
Arm 1a v. Arm II Death	0	2	0
Arm 1a v. Arm II Lack of Efficacy	2	0	0
Arm 1a v. Arm II Lost to Follow-up	2	9	0
Arm 1a v. Arm II Physician Decision	1	1	0
Arm 1a v. Arm II Withdrawal by Subject	5	6	0
Arm Ib v Arm III Adverse Event	9	0	4
Arm Ib v Arm III Death	1	0	1
Arm Ib v Arm III Lack of Efficacy	2	0	2
Arm Ib v Arm III Lost to Follow-up	1	0	3
Arm Ib v Arm III Physician Decision	4	0	1
Arm Ib v Arm III Withdrawal by Subject	7	0	4

Baseline Characteristics

Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=88 Participants Participants assigned to active comparator arm concurrent to Arm II.Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=90 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=95 Participants Participants assigned to active comparator arm concurrent to Arm III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=90 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab: Given IV	Total n=363 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 10.9 • n=3 Participants	56.0 years STANDARD_DEVIATION 9.8 • n=3 Participants	55.7 years STANDARD_DEVIATION 11.2 • n=6 Participants	55.5 years STANDARD_DEVIATION 11.1 • n=3 Participants	55.6 years STANDARD_DEVIATION 10.7 • n=15 Participants
Sex: Female, Male Female	29 Participants n=3 Participants	29 Participants n=3 Participants	29 Participants n=6 Participants	30 Participants n=3 Participants	117 Participants n=15 Participants
Sex: Female, Male Male	59 Participants n=3 Participants	61 Participants n=3 Participants	66 Participants n=6 Participants	60 Participants n=3 Participants	246 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=3 Participants	1 Participants n=3 Participants	5 Participants n=6 Participants	9 Participants n=3 Participants	18 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=3 Participants	86 Participants n=3 Participants	83 Participants n=6 Participants	78 Participants n=3 Participants	331 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=3 Participants	3 Participants n=3 Participants	7 Participants n=6 Participants	3 Participants n=3 Participants	14 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants	1 Participants n=3 Participants	4 Participants n=15 Participants
Race (NIH/OMB) Asian	2 Participants n=3 Participants	8 Participants n=3 Participants	4 Participants n=6 Participants	3 Participants n=3 Participants	17 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	1 Participants n=15 Participants
Race (NIH/OMB) Black or African American	4 Participants n=3 Participants	7 Participants n=3 Participants	6 Participants n=6 Participants	2 Participants n=3 Participants	19 Participants n=15 Participants
Race (NIH/OMB) White	76 Participants n=3 Participants	71 Participants n=3 Participants	77 Participants n=6 Participants	77 Participants n=3 Participants	301 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=3 Participants	1 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	6 Participants n=3 Participants	20 Participants n=15 Participants

PRIMARY outcome

Timeframe: Baseline to up to 3 years

Population: Patients who had a tumor resection and have pathology o the tumor specimen were evaluable for the primary endpoint of NAR score and included in the analysis.

Outcome measures

Outcome measures
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=72 Participants Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=68 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=68 Participants Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=69 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Neoadjuvant Rectal Cancer (NAR) Score	12.6 score on a scale Interval 9.8 to 15.3	13.7 score on a scale Interval 10.2 to 17.2	14.1 score on a scale Interval 10.7 to 17.4	11.5 score on a scale Interval 8.5 to 14.5

SECONDARY outcome

Timeframe: Time from randomization, assessed up to 3 years

Population: Participants with follow-up

Analyzed using the stratified log rank test with strata cT-stage and cN-stage. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Cox regression models will be used to estimate hazard ratios and associated confidence intervals.

Outcome measures

Outcome measures
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=86 Participants Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=89 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=90 Participants Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=85 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Overall Survival	0.922 proportion of participants Interval 0.834 to 0.964	0.849 proportion of participants Interval 0.754 to 0.91	0.867 proportion of participants Interval 0.772 to 0.924	0.950 proportion of participants Interval 0.87 to 0.981

SECONDARY outcome

Timeframe: Time from randomization, assessed up to 3 years

Population: Participants with follow-up

Outcome measures

Outcome measures
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=86 Participants Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=89 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=90 Participants Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=85 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Disease Free Survival	0.675 proportion of participants Interval 0.559 to 0.766	0.600 proportion of participants Interval 0.49 to 0.694	0.638 proportion of participants Interval 0.528 to 0.729	0.636 proportion of participants Interval 0.522 to 0.73

SECONDARY outcome

Timeframe: Up to 3 years

Pathologic Complete Response means no remaining cancer detectable in the pathology sample. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome measures
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=74 Participants Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=71 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=68 Participants Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=69 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0	21.6 percentage of participants Interval 12.9 to 32.7	33.8 percentage of participants Interval 23.0 to 46.0	29.4 percentage of participants Interval 19.0 to 41.7	31.9 percentage of participants Interval 21.2 to 44.2

SECONDARY outcome

Timeframe: Up to 3 years

Sphincter preservation means that the surgical procedure used to remove the tumor did not disturb the sphincter muscle. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome measures
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=80 Participants Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=81 Participants Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Arm Ib (mFOLFOX6, RT, Capecitabine) n=69 Participants Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=69 Participants ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Rate of Sphincter Preservation	52.5 percentage of participants Interval 41.0 to 63.8	59.3 percentage of participants Interval 47.8 to 70.1	71.0 percentage of participants Interval 58.8 to 81.3	59.4 percentage of participants Interval 46.9 to 71.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed using the stratified log rank test with strata cT-stage and cN-stage. Kaplan-Meier plots will illustrate the distribution of time to surgery (TTS) by treatment. Cox regression models will be used to estimate hazard ratios and associated confidence intervals.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days after last study treatment

Will be assessed using Common Terminology for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 beginning April 1, 2018).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Cox regression models will be used to evaluate markers for time-to-event variables. Logistic regression models will be used for binary variables. Models will control for stratification factors and possibly other prognostic variables (e.g. gender or treatment).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will explore the relationship between radiographic findings and pathologic outcomes.

Outcome measures

Outcome data not reported

Adverse Events

Arm Ia (mFOLFOX6, RT, Capecitabine)

Serious events: 16 serious events

Other events: 83 other events

Deaths: 7 deaths

Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)

Serious events: 25 serious events

Other events: 86 other events

Deaths: 14 deaths

Arm Ib (mFOLFOX6, RT, Capecitabine)

Serious events: 21 serious events

Other events: 82 other events

Deaths: 13 deaths

Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)

Serious events: 15 serious events

Other events: 81 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Department of Regulatory Affairs

NRG Oncology

Phone: 412-339-5261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=83 participants at risk Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=88 participants at risk Arm II (mFOLFOX6, RT, capecitabine, veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine) n=84 participants at risk Arm Ib (mFOLFOX6, RT, capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=82 participants at risk Arm Ib (mFOLFOX6, RT, capecitabine, pembrolizumab)
Gastrointestinal disorders Abdominal pain	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.3% 2/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Alanine aminotransferase increased	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Immune system disorders Anaphylaxis	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Blood and lymphatic system disorders Anemia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Anorexia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Psychiatric disorders Anxiety	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Aspartate aminotransferase increased	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Cardiac disorders Atrial fibrillation	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Cardiac disorders Cardiac arrest	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Infections and infestations Catheter related infection	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Colitis	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Enterocolitis	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.3% 2/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Colonic obstruction	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.4% 3/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Colonic perforation	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Constipation	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Dehydration	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.5% 4/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Psychiatric disorders Delusions	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Diarrhea	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.0% 7/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Dyspepsia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Encephalopathy	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
General disorders Fatigue	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Blood and lymphatic system disorders Febrile neutropenia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
General disorders Fever	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Vascular disorders Hypertension	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.8% 6/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.3% 2/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Vascular disorders Hypotension	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Endocrine disorders Hypothyroidism	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Ileus	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.6% 3/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Infections and infestations Infections and infestations - Other, specify	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Intracranial hemorrhage	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.

Other adverse events
Measure	Arm Ia (mFOLFOX6, RT, Capecitabine) n=83 participants at risk Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) n=88 participants at risk Arm II (mFOLFOX6, RT, capecitabine, veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine) n=84 participants at risk Arm Ib (mFOLFOX6, RT, capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) n=82 participants at risk Arm Ib (mFOLFOX6, RT, capecitabine, pembrolizumab)
Gastrointestinal disorders Abdominal pain	12.0% 10/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	23.9% 21/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.3% 7/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.3% 6/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Alanine aminotransferase increased	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	11.9% 10/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.8% 8/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Anal pain	14.5% 12/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	21.6% 19/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.3% 6/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Blood and lymphatic system disorders Anemia	13.3% 11/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	20.5% 18/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	15.5% 13/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	17.1% 14/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Anorexia	14.5% 12/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	27.3% 24/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	17.9% 15/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.9% 4/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Psychiatric disorders Anxiety	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.1% 8/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.9% 4/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.3% 7/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Aspartate aminotransferase increased	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.4% 3/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.0% 5/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.8% 8/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.8% 6/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.3% 7/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Constipation	15.7% 13/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	14.8% 13/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	15.5% 13/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	12.2% 10/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Dehydration	10.8% 9/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	23.9% 21/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	14.3% 12/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.1% 5/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Psychiatric disorders Depression	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.9% 4/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Diarrhea	36.1% 30/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	48.9% 43/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	34.5% 29/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	30.5% 25/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Dysgeusia	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.0% 7/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.6% 3/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.3% 2/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.5% 8/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
General disorders Fatigue	31.3% 26/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	52.3% 46/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	39.3% 33/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	39.0% 32/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hyperglycemia	10.8% 9/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.1% 8/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.0% 5/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Vascular disorders Hypertension	28.9% 24/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	18.2% 16/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	22.6% 19/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	29.3% 24/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Endocrine disorders Hyperthyroidism	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 4/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.1% 8/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.1% 5/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypocalcemia	1.2% 1/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.8% 4/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Metabolism and nutrition disorders Hypokalemia	8.4% 7/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	11.4% 10/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.3% 7/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	13.4% 11/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Vascular disorders Hypotension	8.4% 7/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Endocrine disorders Hypothyroidism	0.00% 0/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	0.00% 0/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	10.7% 9/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Infections and infestations Infections and infestations - Other, specify	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.0% 5/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.9% 4/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Psychiatric disorders Insomnia	6.0% 5/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.4% 3/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.0% 5/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Lymphocyte count decreased	42.2% 35/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	42.0% 37/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	42.9% 36/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	30.5% 25/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Mucositis oral	12.0% 10/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	12.5% 11/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.8% 4/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.5% 7/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Nausea	25.3% 21/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	38.6% 34/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	28.6% 24/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	23.2% 19/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Neutrophil count decreased	43.4% 36/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	56.8% 50/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	47.6% 40/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	41.5% 34/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
General disorders Pain	6.0% 5/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.3% 2/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	4.9% 4/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.1% 1/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.6% 3/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.1% 5/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Paresthesia	3.6% 3/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.1% 8/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Peripheral motor neuropathy	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	5.7% 5/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	2.4% 2/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	1.2% 1/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Nervous system disorders Peripheral sensory neuropathy	21.7% 18/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	23.9% 21/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	29.8% 25/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	31.7% 26/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Investigations Platelet count decreased	12.0% 10/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	17.0% 15/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	25.0% 21/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	18.3% 15/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Proctitis	7.2% 6/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	9.1% 8/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	7.1% 6/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	8.5% 7/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 2/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.4% 3/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	6.0% 5/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	3.7% 3/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.
Gastrointestinal disorders Rectal pain	8.4% 7/83 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	14.8% 13/88 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	19.0% 16/84 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.	14.6% 12/82 • Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months. Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.