Laparoscopic-Assisted Resection or Open Resection in Trea... | NCT00726622

ID	Type	Description	Link
ACOSOG-Z6051
U10CA076001	U.S. NIH Grant/Contract		View source
NCI-2009-00350	Other Identifier	NCI Clinical Trial Reporting Office
CDR0000601816	Registry Identifier	NCI Physician Data Query

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below.

Primary Objective:

To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation.

Secondary Objectives:

To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.

open rectal resection (blood loss, length of stay, pain medicine utilization)
To assess disease free survival and local pelvic recurrence at two years.
To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial.

Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures ≤ 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.

Label	Type	Description	Intervention Names
Arm 1: Open laparotomy and rectal resection	Active Comparator	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.	Procedure: Open laparotomy and rectal resection
Arm 2: Laparoscopic-assisted rectal resection	Experimental	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.	Procedure: Laparoscopic-assisted rectal resection

Name	Type	Description	Arm Group Labels	Other Names
Open laparotomy and rectal resection	Procedure	Patients undergo open laparotomy and rectal resection.	Arm 1: Open laparotomy and rectal resection

Measure	Description	Time Frame
Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.	The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation. Primary endpoint parameters: Circumferential margin > 1 mm Negative distal margin Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.	At time of Surgery

Measure	Description	Time Frame
Completeness of Total Mesorectal Excision (Complete or Nearly Complete)	Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat. The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.

Name	Affiliation	Role
James W. Fleshman, MD	Baylor Health	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Scottsdale		Scottsdale	Arizona	85259-5499	United States
Cancer Care Center at John Muir Health - Concord Campus

PubMed Identifier	Type	Citation	Retractions
26441179	Derived	Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529.

Label	URL
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive	View source

ID	Title	Description
FG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.

The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.

Primary endpoint parameters:

Circumferential margin > 1 mm
Negative distal margin
Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.

All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.

Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.

Posted

Number

95% Confidence Interval

percentage of participants

At time of Surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Units	Counts
Participants	OG000222 OG001240

Title

Denominators

Categories

Title	Measurements
	OG00086.9(82.5 to 91.4) OG00181.7(76.5 to 86.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.41														Non-Inferiority or Equivalence (legacy)	Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.

Secondary

Completeness of Total Mesorectal Excision (Complete or Nearly Complete)

Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.

The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.

Posted

Number

95% Confidence Interval

percentage of participants

At time of surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection

Secondary

Negative Distal Resected Margin

The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.

Posted

Number

95% Confidence Interval

percentage of participants

At time of surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Secondary

Circumferential Margin > 1 mm

The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.

Posted

Number

95% Confidence Interval

percentage of participants

At time of surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Secondary

Length of Stay

The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.

Posted

Mean

Standard Deviation

days

Two weeks post-surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Secondary

Use of Pain Medication

The number of days patients received parenteral narcotics post-surgery were counted.

Posted

Mean

Standard Deviation

days

Two weeks post-surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Secondary

Operative Times

Open to close operative time.

Posted

Mean

Standard Deviation

minutes

During surgery

ID	Title	Description
OG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
OG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Secondary

Disease-free Survival

Not Posted

Up to 2 years post surgery

Participants

Secondary

Local Pelvic Recurrence Rates

Not Posted

Up to 2 years post surgery

Participants

Secondary

Overall Survival

Not Posted

Up to 5 years post surgery

Participants

Secondary

Quality of Life and Sexual Function

Not Posted

Up to 5 years post surgery

Participants

Secondary

Bowel Function

Not Posted

Up to 5 years post surgery

Participants

Secondary

Bowel and Stoma Function

Not Posted

Up to 5 years post surgery

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Atrial flutter	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Fecal incontinence	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Ileus	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Nausea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Rectal fistula	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Rectal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events2 affected242 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0012 events2 affected242 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Edema limbs	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Fatigue	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Fever	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Multi-organ failure	General disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Pain	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Abdominal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events1 affected242 at risk
Pelvic infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Sepsis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Urinary tract infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Intraoperative complications	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events1 affected242 at risk
Intraoperative gastrointestinal injury - Pancreas	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Cardiac troponin T increased	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Creatine phosphokinase increased	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Creatinine increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
INR increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Laboratory test abnormal	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Platelet count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Weight loss	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Anxiety	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Confusion	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Depression	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Glomerular filtration rate decreased	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Renal failure	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0010 events0 affected242 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected242 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Hypertension	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Hypotension	Vascular disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Thrombosis	Vascular disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood disorder	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00013 events3 affected239 at risk EG0016 events3 affected242 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00051 events33 affected239 at risk EG00146 events31 affected242 at risk
Hemolysis	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Arrhythmia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0009 events5 affected239 at risk EG0015 events5 affected242 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected239 at risk EG0011 events1 affected242 at risk
Cardiac disorder	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0004 events2 affected239 at risk EG0012 events1 affected242 at risk
Cardiac pain	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected239 at risk EG0014 events4 affected242 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected239 at risk EG0010 events0 affected242 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0007 events7 affected239 at risk EG0018 events8 affected242 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events4 affected242 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Endocrine disorder	Endocrine disorders	MedDRA 10	Systematic Assessment	EG0003 events2 affected239 at risk EG0010 events0 affected242 at risk
Extraocular muscle paresis	Eye disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Vision blurred	Eye disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Watering eyes	Eye disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00019 events14 affected239 at risk EG00116 events12 affected242 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00057 events32 affected239 at risk EG00172 events45 affected242 at risk
Anal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected242 at risk
Anal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0017 events5 affected242 at risk
Ascites	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected242 at risk
Cecal obstruction	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Colitis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0012 events2 affected242 at risk
Constipation	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00023 events18 affected239 at risk EG00120 events18 affected242 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00087 events43 affected239 at risk EG00174 events44 affected242 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected239 at risk EG0012 events2 affected242 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected242 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0012 events2 affected242 at risk
Enteritis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events1 affected242 at risk
Esophageal varices hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events1 affected242 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Fecal incontinence	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG000117 events64 affected239 at risk EG001101 events53 affected242 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events6 affected239 at risk EG0017 events5 affected242 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00037 events24 affected239 at risk EG00143 events31 affected242 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0007 events5 affected239 at risk EG0011 events1 affected242 at risk
Ileal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Ileus	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00047 events39 affected239 at risk EG00140 events35 affected242 at risk
Intra-abdominal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Nausea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00070 events43 affected239 at risk EG00188 events54 affected242 at risk
Oral hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Oral pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Proctitis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Proctoscopy abnormal	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Rectal fistula	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00028 events16 affected239 at risk EG00112 events8 affected242 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected239 at risk EG0018 events8 affected242 at risk
Rectal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG000149 events79 affected239 at risk EG001153 events85 affected242 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Rectal stenosis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00021 events12 affected239 at risk EG00128 events14 affected242 at risk
Salivary gland disorder	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected242 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00028 events24 affected239 at risk EG00119 events17 affected242 at risk
Stomach pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected242 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00028 events22 affected239 at risk EG00136 events25 affected242 at risk
Chest pain	General disorders	MedDRA 10	Systematic Assessment	EG0007 events6 affected239 at risk EG0014 events4 affected242 at risk
Chills	General disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0014 events4 affected242 at risk
Disease progression	General disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Edema limbs	General disorders	MedDRA 10	Systematic Assessment	EG00013 events10 affected239 at risk EG00112 events11 affected242 at risk
Facial pain	General disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Fatigue	General disorders	MedDRA 10	Systematic Assessment	EG000114 events49 affected239 at risk EG00173 events48 affected242 at risk
Fever	General disorders	MedDRA 10	Systematic Assessment	EG00023 events19 affected239 at risk EG00134 events27 affected242 at risk
Flu-like symptoms	General disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Gait abnormal	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events2 affected242 at risk
General symptom	General disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0014 events4 affected242 at risk
Localized edema	General disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected242 at risk
Pain	General disorders	MedDRA 10	Systematic Assessment	EG00031 events20 affected239 at risk EG00127 events19 affected242 at risk
Visceral edema	General disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Hypersensitivity	Immune system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0010 events0 affected242 at risk
Immune system disorder	Immune system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Abdominal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0007 events6 affected239 at risk EG0014 events3 affected242 at risk
Anal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0012 events2 affected242 at risk
Anorectal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0005 events5 affected239 at risk EG0011 events1 affected242 at risk
Appendicitis perforated	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Bladder infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events4 affected242 at risk
Bronchitis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Colitis, infectious (e.g., Clostridium difficile)	Infections and infestations	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0016 events4 affected242 at risk
Device related infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected242 at risk
Eye infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Ileal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG00026 events13 affected239 at risk EG00123 events15 affected242 at risk
Infectious colitis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Kidney infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0003 events2 affected239 at risk EG0010 events0 affected242 at risk
Lip infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Mucosal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Nail infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Pelvic infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0007 events5 affected239 at risk EG0013 events3 affected242 at risk
Peritoneal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0004 events3 affected239 at risk EG0011 events1 affected242 at risk
Phlebitis infective	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Pneumonia	Infections and infestations	MedDRA 10	Systematic Assessment	EG0004 events3 affected239 at risk EG0010 events0 affected242 at risk
Scrotal infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Sepsis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0007 events6 affected239 at risk EG0013 events3 affected242 at risk
Sinusitis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Skin infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0005 events3 affected239 at risk EG0015 events5 affected242 at risk
Soft tissue infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Stoma site infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Upper respiratory infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0012 events2 affected242 at risk
Urinary tract infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG00021 events17 affected239 at risk EG00120 events16 affected242 at risk
Wound infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG00023 events17 affected239 at risk EG00121 events17 affected242 at risk
Bruising	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected242 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events3 affected242 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0003 events2 affected239 at risk EG0010 events0 affected242 at risk
Intestinal stoma leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected242 at risk
Intestinal stoma obstruction	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Intestinal stoma site bleeding	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0006 events6 affected239 at risk EG0013 events3 affected242 at risk
Intraoperative complications	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG00029 events21 affected239 at risk EG00128 events14 affected242 at risk
Intraoperative neurological injury - NERVES: CN IX (glossopharyngeal) motor pharynx	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Large intestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0004 events2 affected239 at risk EG0013 events3 affected242 at risk
Postoperative hemorrhage	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0005 events5 affected239 at risk EG0016 events5 affected242 at risk
Prolapse of intestinal stoma	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0006 events5 affected239 at risk EG0013 events3 affected242 at risk
Rectal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG00011 events8 affected239 at risk EG0016 events5 affected242 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0006 events6 affected239 at risk EG0012 events2 affected242 at risk
Small intestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected242 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Tracheostomy site bleeding	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Ureteric anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Urethral anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Urostomy leak	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG00037 events26 affected239 at risk EG00134 events18 affected242 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG0008 events4 affected239 at risk EG0016 events3 affected242 at risk
Alkaline phosphatase increased	Investigations	MedDRA 10	Systematic Assessment	EG0009 events4 affected239 at risk EG0013 events2 affected242 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG0007 events4 affected239 at risk EG0017 events4 affected242 at risk
Bilirubin increased	Investigations	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0012 events2 affected242 at risk
Cardiac troponin I increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Coagulopathy	Investigations	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0013 events3 affected242 at risk
Creatine phosphokinase increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Creatinine increased	Investigations	MedDRA 10	Systematic Assessment	EG0008 events7 affected239 at risk EG0018 events7 affected242 at risk
INR increased	Investigations	MedDRA 10	Systematic Assessment	EG0002 events1 affected239 at risk EG0013 events2 affected242 at risk
Laboratory test abnormal	Investigations	MedDRA 10	Systematic Assessment	EG00017 events9 affected239 at risk EG00110 events6 affected242 at risk
Leukocyte count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0006 events5 affected239 at risk EG00118 events13 affected242 at risk
Lymphocyte count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0018 events6 affected242 at risk
Neutrophil count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0018 events7 affected242 at risk
Platelet count decreased	Investigations	MedDRA 10	Systematic Assessment	EG00015 events10 affected239 at risk EG00112 events9 affected242 at risk
Serum cholesterol increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Weight gain	Investigations	MedDRA 10	Systematic Assessment	EG0004 events2 affected239 at risk EG0011 events1 affected242 at risk
Weight loss	Investigations	MedDRA 10	Systematic Assessment	EG00027 events16 affected239 at risk EG00121 events13 affected242 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00029 events22 affected239 at risk EG00120 events14 affected242 at risk
Blood bicarbonate decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00017 events11 affected239 at risk EG00123 events11 affected242 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00032 events26 affected239 at risk EG00122 events14 affected242 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0008 events8 affected239 at risk EG0013 events3 affected242 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00010 events9 affected239 at risk EG0016 events5 affected242 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0008 events6 affected239 at risk EG0013 events2 affected242 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0015 events5 affected242 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00018 events14 affected239 at risk EG00113 events11 affected242 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0015 events5 affected242 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0009 events8 affected239 at risk EG0016 events6 affected242 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0015 events3 affected242 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG00023 events11 affected239 at risk EG00111 events8 affected242 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected242 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events2 affected242 at risk
Joint pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0009 events7 affected239 at risk EG0012 events2 affected242 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected239 at risk EG00110 events8 affected242 at risk
Muscle weakness trunk	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG00010 events6 affected239 at risk EG0018 events8 affected242 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0007 events2 affected239 at risk EG0016 events5 affected242 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0009 events6 affected239 at risk EG0018 events7 affected242 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Dizziness	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00012 events10 affected239 at risk EG0019 events8 affected242 at risk
Encephalopathy	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Headache	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0006 events3 affected239 at risk EG0019 events8 affected242 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events3 affected242 at risk
Memory impairment	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Myelitis	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Nervous system disorders - Other, specify	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Neuralgia	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG00110 events5 affected242 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0005 events1 affected239 at risk EG0017 events5 affected242 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00072 events35 affected239 at risk EG00183 events39 affected242 at risk
Radiculitis brachial	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Seizure	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Syncope	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events2 affected239 at risk EG0013 events3 affected242 at risk
Taste alteration	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0013 events2 affected242 at risk
Agitation	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0004 events2 affected239 at risk EG0010 events0 affected242 at risk
Anxiety	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG00011 events8 affected239 at risk EG00112 events4 affected242 at risk
Confusion	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0014 events4 affected242 at risk
Depression	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG00026 events10 affected239 at risk EG00130 events16 affected242 at risk
Insomnia	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG00016 events9 affected239 at risk EG00120 events12 affected242 at risk
Libido decreased	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0004 events3 affected239 at risk EG0012 events1 affected242 at risk
Orgasm abnormal	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG000124 events50 affected239 at risk EG00195 events39 affected242 at risk
Psychosis	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Bladder hemorrhage	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Glomerular filtration rate decreased	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0004 events2 affected239 at risk EG0012 events2 affected242 at risk
Hemoglobin urine positive	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Hemorrhage urinary tract	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Renal failure	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0007 events7 affected239 at risk EG0015 events5 affected242 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0005 events3 affected239 at risk EG0012 events2 affected242 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected239 at risk EG0011 events1 affected242 at risk
Urethral pain	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Urinary frequency	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0008 events7 affected239 at risk EG00112 events7 affected242 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0008 events4 affected239 at risk EG0016 events6 affected242 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG00043 events26 affected239 at risk EG00154 events40 affected242 at risk
Urine discoloration	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG00011 events8 affected239 at risk EG0014 events4 affected242 at risk
Vesical fistula	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Ejaculation disorder	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0008 events3 affected239 at risk EG0012 events2 affected242 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG000177 events65 affected239 at risk EG001152 events64 affected242 at risk
Gynecomastia	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Irregular menstruation	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected239 at risk EG0013 events3 affected242 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG00011 events5 affected239 at risk EG00126 events11 affected242 at risk
Reproductive tract disorder	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Vaginal atresia	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected242 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Vaginal dryness	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events3 affected242 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Vaginal pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected242 at risk
Vaginal stricture	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0014 events3 affected242 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected239 at risk EG0010 events0 affected242 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG00012 events6 affected239 at risk EG0015 events5 affected242 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG00013 events9 affected239 at risk EG00114 events11 affected242 at risk
Hemorrhage nasal	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Hiccough	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected239 at risk EG0013 events3 affected242 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Mediastinal hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Pharyngeal mucositis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected242 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0007 events7 affected239 at risk EG0015 events5 affected242 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0017 events6 affected242 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG00110 events6 affected242 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0004 events3 affected239 at risk EG0015 events4 affected242 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected239 at risk EG0010 events0 affected242 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0005 events3 affected239 at risk EG0013 events3 affected242 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected242 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00011 events8 affected239 at risk EG0016 events6 affected242 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected242 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00015 events11 affected239 at risk EG0017 events5 affected242 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00018 events12 affected239 at risk EG00129 events19 affected242 at risk
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected242 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0014 events4 affected242 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0003 events2 affected239 at risk EG0014 events4 affected242 at risk
Hematoma	Vascular disorders	MedDRA 10	Systematic Assessment	EG0007 events6 affected239 at risk EG0015 events5 affected242 at risk
Hemorrhage	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected242 at risk
Hot flashes	Vascular disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0012 events2 affected242 at risk
Hypertension	Vascular disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected239 at risk EG0019 events7 affected242 at risk
Hypotension	Vascular disorders	MedDRA 10	Systematic Assessment	EG00013 events12 affected239 at risk EG0019 events8 affected242 at risk
Lymph leakage	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected242 at risk
Thrombosis	Vascular disorders	MedDRA 10	Systematic Assessment	EG00014 events10 affected239 at risk EG00110 events9 affected242 at risk
Vascular disorder	Vascular disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events1 affected242 at risk

ID	Term
D015179	Colorectal Neoplasms
D012004	Rectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

ID	Title	Description
BG000	Arm 1: Open Laparotomy and Rectal Resection	Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
BG001	Arm 2: Laparoscopic-assisted Rectal Resection	Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1: Open Laparotomy and Rectal Resection	Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.			11	239	201	239
EG001	Arm 2: Laparoscopic-assisted Rectal Resection	Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.			10	242	207	242