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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00726622
Recruitment Status : Active, not recruiting
First Posted : August 1, 2008
Results First Posted : November 11, 2016
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Procedure: Open laparotomy and rectal resection
Procedure: Laparoscopic-assisted rectal resection
Enrollment 486
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 243 243
Completed 225 240
Not Completed 18 3
Reason Not Completed
Withdrawal by Subject             16             2
Physician Decision             0             1
Metastasis             2             0
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 239 242 481
Hide Baseline Analysis Population Description
All patients that were randomized to a treatment arm were available for baseline characteristics. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants 242 participants 481 participants
57.2  (12.1) 57.7  (11.5) 57.4  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 242 participants 481 participants
Female
81
  33.9%
86
  35.5%
167
  34.7%
Male
158
  66.1%
156
  64.5%
314
  65.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 239 participants 242 participants 481 participants
239 242 481
1.Primary Outcome
Title 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.
Hide Description

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.

Time Frame At time of Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.9
(82.5 to 91.4)
81.7
(76.5 to 86.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Open Laparotomy and Rectal Resection, Arm 2: Laparoscopic-assisted Rectal Resection
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Completeness of Total Mesorectal Excision (Complete or Nearly Complete)
Hide Description

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.

Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.1
(92.2 to 97.9)
92.1
(88.7 to 95.5)
3.Secondary Outcome
Title Negative Distal Resected Margin
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.2
(96.5 to 99.95)
98.3
(96.7 to 99.95)
4.Secondary Outcome
Title Circumferential Margin > 1 mm
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.3
(88.8 to 95.8)
87.9
(83.8 to 92.0)
5.Secondary Outcome
Title Length of Stay
Hide Description The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.
Time Frame Two weeks post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Mean (Standard Deviation)
Unit of Measure: days
7.0  (3.4) 7.3  (5.4)
6.Secondary Outcome
Title Use of Pain Medication
Hide Description The number of days patients received parenteral narcotics post-surgery were counted.
Time Frame Two weeks post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Mean (Standard Deviation)
Unit of Measure: days
4.2  (2.8) 4.2  (3.9)
7.Secondary Outcome
Title Operative Times
Hide Description Open to close operative time.
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 222 240
Mean (Standard Deviation)
Unit of Measure: minutes
220.6  (92.4) 266.2  (101.9)
8.Secondary Outcome
Title Disease-free Survival
Hide Description [Not Specified]
Time Frame Up to 2 years post surgery
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Local Pelvic Recurrence Rates
Hide Description [Not Specified]
Time Frame Up to 2 years post surgery
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Up to 5 years post surgery
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Quality of Life and Sexual Function
Hide Description [Not Specified]
Time Frame Up to 5 years post surgery
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Bowel Function
Hide Description [Not Specified]
Time Frame Up to 5 years post surgery
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Bowel and Stoma Function
Hide Description [Not Specified]
Time Frame Up to 5 years post surgery
Outcome Measure Data Not Reported
Time Frame Adverse Events were collected after surgery and were collected up to 30 days after surgery.
Adverse Event Reporting Description All patients that were randomized to a treatment arm were available for adverse event analysis. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent. Therefore, this analysis is based on 239 patients on Arm 1 and 242 Patients on Arm 2.
 
Arm/Group Title Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Hide Arm/Group Description Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection. Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
All-Cause Mortality
Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/239 (4.60%)      10/242 (4.13%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Cardiac disorders     
Arrhythmia supraventricular  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Atrial fibrillation  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Atrial flutter  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Cardiac valve disease  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Left ventricular dysfunction  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Myocardial ischemia  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Pericardial effusion  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Sinus tachycardia  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Ventricular tachycardia  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Gastrointestinal disorders     
Abdominal distension  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Abdominal pain  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Diarrhea  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Fecal incontinence  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Gastrointestinal disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Ileus  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Nausea  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Rectal fistula  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Rectal pain  1  0/239 (0.00%)  0 2/242 (0.83%)  3
Small intestinal obstruction  1  2/239 (0.84%)  2 2/242 (0.83%)  2
Vomiting  1  0/239 (0.00%)  0 1/242 (0.41%)  1
General disorders     
Edema limbs  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Fatigue  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Fever  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Multi-organ failure  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Infections and infestations     
Abdominal infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Infection  1  1/239 (0.42%)  1 1/242 (0.41%)  2
Pelvic infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Sepsis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Urinary tract infection  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Injury, poisoning and procedural complications     
Intraoperative complications  1  1/239 (0.42%)  1 1/242 (0.41%)  2
Intraoperative gastrointestinal injury - Pancreas  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Wound dehiscence  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Cardiac troponin T increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Creatine phosphokinase increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Creatinine increased  1  1/239 (0.42%)  1 1/242 (0.41%)  1
INR increased  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Laboratory test abnormal  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Platelet count decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Weight loss  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Blood glucose increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Dehydration  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Serum albumin decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum calcium decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum magnesium decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum magnesium increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum phosphate decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum potassium decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum potassium increased  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Serum sodium decreased  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Serum triglycerides increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Buttock pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Chest wall pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Muscle weakness  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Nervous system disorders     
Neurological disorder NOS  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Psychiatric disorders     
Anxiety  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Confusion  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Depression  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Renal and urinary disorders     
Glomerular filtration rate decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Renal failure  1  3/239 (1.26%)  3 0/242 (0.00%)  0
Urinary retention  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Urogenital disorder  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Reproductive system and breast disorders     
Erectile dysfunction  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Perineal pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Dyspnea  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Hypoxia  1  1/239 (0.42%)  1 2/242 (0.83%)  2
Pleural effusion  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Pneumonitis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Pneumothorax  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Respiratory disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Skin disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Vascular disorders     
Hypertension  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Hypotension  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Thrombosis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Open Laparotomy and Rectal Resection Arm 2: Laparoscopic-assisted Rectal Resection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   201/239 (84.10%)      207/242 (85.54%)    
Blood and lymphatic system disorders     
Blood disorder  1  3/239 (1.26%)  13 3/242 (1.24%)  6
Disseminated intravascular coagulation  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Febrile neutropenia  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Hemoglobin decreased  1  33/239 (13.81%)  51 31/242 (12.81%)  46
Hemolysis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Lymphatic disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Thrombotic microangiopathy  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Cardiac disorders     
Arrhythmia  1  5/239 (2.09%)  9 5/242 (2.07%)  5
Atrial fibrillation  1  4/239 (1.67%)  5 1/242 (0.41%)  1
Cardiac disorder  1  2/239 (0.84%)  4 1/242 (0.41%)  2
Cardiac pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Left ventricular dysfunction  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Myocardial ischemia  1  4/239 (1.67%)  5 4/242 (1.65%)  4
Pericardial effusion  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Restrictive cardiomyopathy  1  1/239 (0.42%)  2 0/242 (0.00%)  0
Sinus bradycardia  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Sinus tachycardia  1  7/239 (2.93%)  7 8/242 (3.31%)  8
Ventricular arrhythmia  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Ventricular tachycardia  1  1/239 (0.42%)  1 4/242 (1.65%)  4
Ear and labyrinth disorders     
Tinnitus  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Endocrine disorders     
Endocrine disorder  1  2/239 (0.84%)  3 0/242 (0.00%)  0
Eye disorders     
Extraocular muscle paresis  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Vision blurred  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Watering eyes  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  14/239 (5.86%)  19 12/242 (4.96%)  16
Abdominal pain  1  32/239 (13.39%)  57 45/242 (18.60%)  72
Anal hemorrhage  1  1/239 (0.42%)  1 3/242 (1.24%)  3
Anal pain  1  4/239 (1.67%)  4 5/242 (2.07%)  7
Ascites  1  1/239 (0.42%)  1 2/242 (0.83%)  2
Cecal obstruction  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Colitis  1  2/239 (0.84%)  2 2/242 (0.83%)  2
Constipation  1  18/239 (7.53%)  23 18/242 (7.44%)  20
Diarrhea  1  43/239 (17.99%)  87 44/242 (18.18%)  74
Dry mouth  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Dyspepsia  1  4/239 (1.67%)  5 2/242 (0.83%)  2
Dysphagia  1  1/239 (0.42%)  1 3/242 (1.24%)  3
Ear, nose and throat examination abnormal  1  4/239 (1.67%)  4 2/242 (0.83%)  2
Enteritis  1  1/239 (0.42%)  1 1/242 (0.41%)  2
Esophageal varices hemorrhage  1  0/239 (0.00%)  0 1/242 (0.41%)  3
Esophagitis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Fecal incontinence  1  64/239 (26.78%)  117 53/242 (21.90%)  101
Flatulence  1  6/239 (2.51%)  6 5/242 (2.07%)  7
Gastritis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Gastrointestinal disorder  1  24/239 (10.04%)  37 31/242 (12.81%)  43
Gastrointestinal fistula  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Gastrointestinal pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Hemorrhoids  1  5/239 (2.09%)  7 1/242 (0.41%)  1
Ileal hemorrhage  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Ileus  1  39/239 (16.32%)  47 35/242 (14.46%)  40
Intra-abdominal hemorrhage  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Lower gastrointestinal hemorrhage  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Mucositis oral  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Nausea  1  43/239 (17.99%)  70 54/242 (22.31%)  88
Oral hemorrhage  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Oral pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Pancreatitis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Proctitis  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Proctoscopy abnormal  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Rectal fistula  1  16/239 (6.69%)  28 8/242 (3.31%)  12
Rectal hemorrhage  1  5/239 (2.09%)  6 8/242 (3.31%)  8
Rectal pain  1  79/239 (33.05%)  149 85/242 (35.12%)  153
Rectal perforation  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Rectal stenosis  1  12/239 (5.02%)  21 14/242 (5.79%)  28
Salivary gland disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  2
Small intestinal obstruction  1  24/239 (10.04%)  28 17/242 (7.02%)  19
Stomach pain  1  1/239 (0.42%)  1 3/242 (1.24%)  3
Upper gastrointestinal hemorrhage  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Vomiting  1  22/239 (9.21%)  28 25/242 (10.33%)  36
General disorders     
Chest pain  1  6/239 (2.51%)  7 4/242 (1.65%)  4
Chills  1  4/239 (1.67%)  4 4/242 (1.65%)  4
Disease progression  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Edema limbs  1  10/239 (4.18%)  13 11/242 (4.55%)  12
Facial pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Fatigue  1  49/239 (20.50%)  114 48/242 (19.83%)  73
Fever  1  19/239 (7.95%)  23 27/242 (11.16%)  34
Flu-like symptoms  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Gait abnormal  1  0/239 (0.00%)  0 2/242 (0.83%)  3
General symptom  1  3/239 (1.26%)  3 4/242 (1.65%)  4
Localized edema  1  1/239 (0.42%)  1 3/242 (1.24%)  3
Pain  1  20/239 (8.37%)  31 19/242 (7.85%)  27
Visceral edema  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Hepatic failure  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Hepatobiliary disease  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Immune system disorders     
Hypersensitivity  1  3/239 (1.26%)  3 0/242 (0.00%)  0
Immune system disorder  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Infections and infestations     
Abdominal infection  1  6/239 (2.51%)  7 3/242 (1.24%)  4
Anal infection  1  3/239 (1.26%)  3 2/242 (0.83%)  2
Anorectal infection  1  5/239 (2.09%)  5 1/242 (0.41%)  1
Appendicitis perforated  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Bladder infection  1  1/239 (0.42%)  1 4/242 (1.65%)  4
Bronchitis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Colitis, infectious (e.g., Clostridium difficile)  1  3/239 (1.26%)  3 4/242 (1.65%)  6
Device related infection  1  0/239 (0.00%)  0 1/242 (0.41%)  2
Eye infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Ileal infection  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Infection  1  13/239 (5.44%)  26 15/242 (6.20%)  23
Infectious colitis  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Kidney infection  1  2/239 (0.84%)  3 0/242 (0.00%)  0
Lip infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Mucosal infection  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Nail infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Pelvic infection  1  5/239 (2.09%)  7 3/242 (1.24%)  3
Peritoneal infection  1  3/239 (1.26%)  4 1/242 (0.41%)  1
Phlebitis infective  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Pneumonia  1  3/239 (1.26%)  4 0/242 (0.00%)  0
Scrotal infection  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Sepsis  1  6/239 (2.51%)  7 3/242 (1.24%)  3
Sinusitis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Skin infection  1  3/239 (1.26%)  5 5/242 (2.07%)  5
Soft tissue infection  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Stoma site infection  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Upper respiratory infection  1  2/239 (0.84%)  2 2/242 (0.83%)  2
Urinary tract infection  1  17/239 (7.11%)  21 16/242 (6.61%)  20
Wound infection  1  17/239 (7.11%)  23 17/242 (7.02%)  21
Injury, poisoning and procedural complications     
Bruising  1  1/239 (0.42%)  1 2/242 (0.83%)  2
Fracture  1  0/239 (0.00%)  0 3/242 (1.24%)  3
Gastrointestinal anastomotic leak  1  2/239 (0.84%)  3 0/242 (0.00%)  0
Intestinal stoma leak  1  3/239 (1.26%)  3 1/242 (0.41%)  1
Intestinal stoma obstruction  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Intestinal stoma site bleeding  1  6/239 (2.51%)  6 3/242 (1.24%)  3
Intraoperative complications  1  21/239 (8.79%)  29 14/242 (5.79%)  28
Intraoperative neurological injury - NERVES: CN IX (glossopharyngeal) motor pharynx  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Large intestinal anastomotic leak  1  2/239 (0.84%)  4 3/242 (1.24%)  3
Postoperative hemorrhage  1  5/239 (2.09%)  5 5/242 (2.07%)  6
Prolapse of intestinal stoma  1  5/239 (2.09%)  6 3/242 (1.24%)  3
Rectal anastomotic leak  1  8/239 (3.35%)  11 5/242 (2.07%)  6
Seroma  1  6/239 (2.51%)  6 2/242 (0.83%)  2
Small intestinal anastomotic leak  1  0/239 (0.00%)  0 1/242 (0.41%)  2
Thermal burn  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Tracheostomy site bleeding  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Ureteric anastomotic leak  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Urethral anastomotic leak  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Urostomy leak  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Vascular access complication  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Wound dehiscence  1  26/239 (10.88%)  37 18/242 (7.44%)  34
Investigations     
Alanine aminotransferase increased  1  4/239 (1.67%)  8 3/242 (1.24%)  6
Alkaline phosphatase increased  1  4/239 (1.67%)  9 2/242 (0.83%)  3
Aspartate aminotransferase increased  1  4/239 (1.67%)  7 4/242 (1.65%)  7
Bilirubin increased  1  2/239 (0.84%)  2 2/242 (0.83%)  2
Cardiac troponin I increased  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Coagulopathy  1  2/239 (0.84%)  2 3/242 (1.24%)  3
Creatine phosphokinase increased  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Creatinine increased  1  7/239 (2.93%)  8 7/242 (2.89%)  8
INR increased  1  1/239 (0.42%)  2 2/242 (0.83%)  3
Laboratory test abnormal  1  9/239 (3.77%)  17 6/242 (2.48%)  10
Leukocyte count decreased  1  5/239 (2.09%)  6 13/242 (5.37%)  18
Lymphocyte count decreased  1  2/239 (0.84%)  2 6/242 (2.48%)  8
Neutrophil count decreased  1  4/239 (1.67%)  4 7/242 (2.89%)  8
Platelet count decreased  1  10/239 (4.18%)  15 9/242 (3.72%)  12
Serum cholesterol increased  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Weight gain  1  2/239 (0.84%)  4 1/242 (0.41%)  1
Weight loss  1  16/239 (6.69%)  27 13/242 (5.37%)  21
Metabolism and nutrition disorders     
Acidosis  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Anorexia  1  22/239 (9.21%)  29 14/242 (5.79%)  20
Blood bicarbonate decreased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Blood glucose increased  1  11/239 (4.60%)  17 11/242 (4.55%)  23
Dehydration  1  26/239 (10.88%)  32 14/242 (5.79%)  22
Serum albumin decreased  1  8/239 (3.35%)  8 3/242 (1.24%)  3
Serum calcium decreased  1  9/239 (3.77%)  10 5/242 (2.07%)  6
Serum calcium increased  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Serum magnesium decreased  1  6/239 (2.51%)  8 2/242 (0.83%)  3
Serum magnesium increased  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Serum phosphate decreased  1  3/239 (1.26%)  3 5/242 (2.07%)  5
Serum potassium decreased  1  14/239 (5.86%)  18 11/242 (4.55%)  13
Serum potassium increased  1  1/239 (0.42%)  1 5/242 (2.07%)  5
Serum sodium decreased  1  8/239 (3.35%)  9 6/242 (2.48%)  6
Serum sodium increased  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Serum triglycerides increased  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/239 (0.42%)  1 3/242 (1.24%)  5
Back pain  1  11/239 (4.60%)  23 8/242 (3.31%)  11
Bone pain  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Buttock pain  1  1/239 (0.42%)  1 3/242 (1.24%)  3
Chest wall pain  1  1/239 (0.42%)  1 2/242 (0.83%)  4
Joint pain  1  7/239 (2.93%)  9 2/242 (0.83%)  2
Muscle weakness  1  5/239 (2.09%)  6 8/242 (3.31%)  10
Muscle weakness trunk  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Muscle weakness upper limb  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Musculoskeletal disorder  1  6/239 (2.51%)  10 8/242 (3.31%)  8
Myalgia  1  2/239 (0.84%)  7 5/242 (2.07%)  6
Neck pain  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Pain in extremity  1  6/239 (2.51%)  9 7/242 (2.89%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Nervous system disorders     
Dizziness  1  10/239 (4.18%)  12 8/242 (3.31%)  9
Encephalopathy  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Headache  1  3/239 (1.26%)  6 8/242 (3.31%)  9
Ischemia cerebrovascular  1  0/239 (0.00%)  0 3/242 (1.24%)  3
Memory impairment  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Myelitis  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Nervous system disorders - Other, specify  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Neuralgia  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Neurological disorder NOS  1  4/239 (1.67%)  4 5/242 (2.07%)  10
Peripheral motor neuropathy  1  1/239 (0.42%)  5 5/242 (2.07%)  7
Peripheral sensory neuropathy  1  35/239 (14.64%)  72 39/242 (16.12%)  83
Radiculitis brachial  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Seizure  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Syncope  1  2/239 (0.84%)  3 3/242 (1.24%)  3
Taste alteration  1  3/239 (1.26%)  3 2/242 (0.83%)  3
Psychiatric disorders     
Agitation  1  2/239 (0.84%)  4 0/242 (0.00%)  0
Anxiety  1  8/239 (3.35%)  11 4/242 (1.65%)  12
Confusion  1  4/239 (1.67%)  4 4/242 (1.65%)  4
Depression  1  10/239 (4.18%)  26 16/242 (6.61%)  30
Insomnia  1  9/239 (3.77%)  16 12/242 (4.96%)  20
Libido decreased  1  3/239 (1.26%)  4 1/242 (0.41%)  2
Orgasm abnormal  1  50/239 (20.92%)  124 39/242 (16.12%)  95
Psychosis  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Renal and urinary disorders     
Bladder hemorrhage  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Bladder spasm  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Glomerular filtration rate decreased  1  2/239 (0.84%)  4 2/242 (0.83%)  2
Hemoglobin urine positive  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Hemorrhage urinary tract  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Renal failure  1  7/239 (2.93%)  7 5/242 (2.07%)  5
Ureteric obstruction  1  3/239 (1.26%)  5 2/242 (0.83%)  2
Ureteric stenosis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Urethral obstruction  1  1/239 (0.42%)  2 1/242 (0.41%)  1
Urethral pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Urinary frequency  1  7/239 (2.93%)  8 7/242 (2.89%)  12
Urinary incontinence  1  4/239 (1.67%)  8 6/242 (2.48%)  6
Urinary retention  1  26/239 (10.88%)  43 40/242 (16.53%)  54
Urine discoloration  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Urogenital disorder  1  8/239 (3.35%)  11 4/242 (1.65%)  4
Vesical fistula  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Reproductive system and breast disorders     
Breast pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Ejaculation disorder  1  3/239 (1.26%)  8 2/242 (0.83%)  2
Erectile dysfunction  1  65/239 (27.20%)  177 64/242 (26.45%)  152
Gynecomastia  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Irregular menstruation  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Pelvic pain  1  4/239 (1.67%)  4 3/242 (1.24%)  3
Penile pain  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Perineal pain  1  5/239 (2.09%)  11 11/242 (4.55%)  26
Reproductive tract disorder  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Vaginal atresia  1  1/239 (0.42%)  1 2/242 (0.83%)  2
Vaginal discharge  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Vaginal dryness  1  1/239 (0.42%)  1 3/242 (1.24%)  4
Vaginal hemorrhage  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Vaginal inflammation  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Vaginal pain  1  1/239 (0.42%)  1 2/242 (0.83%)  2
Vaginal stricture  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  0/239 (0.00%)  0 3/242 (1.24%)  4
Allergic rhinitis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Aspiration  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Atelectasis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Bronchospasm  1  1/239 (0.42%)  2 0/242 (0.00%)  0
Chylothorax  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Cough  1  6/239 (2.51%)  12 5/242 (2.07%)  5
Dyspnea  1  9/239 (3.77%)  13 11/242 (4.55%)  14
Hemorrhage nasal  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Hiccough  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Hypoxia  1  5/239 (2.09%)  5 3/242 (1.24%)  3
Laryngeal edema  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Mediastinal hemorrhage  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Nasal congestion  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Pharyngeal mucositis  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Pharyngolaryngeal pain  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Pleural effusion  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Pleuritic pain  1  2/239 (0.84%)  2 0/242 (0.00%)  0
Pneumonitis  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Pulmonary hypertension  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Respiratory disorder  1  7/239 (2.93%)  7 5/242 (2.07%)  5
Voice alteration  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/239 (0.00%)  0 6/242 (2.48%)  7
Decubitus ulcer  1  0/239 (0.00%)  0 6/242 (2.48%)  10
Dry skin  1  3/239 (1.26%)  4 4/242 (1.65%)  5
Erythema multiforme  1  1/239 (0.42%)  2 0/242 (0.00%)  0
Hand-and-foot syndrome  1  3/239 (1.26%)  5 3/242 (1.24%)  3
Pain of skin  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Petechiae  1  1/239 (0.42%)  1 1/242 (0.41%)  1
Pruritus  1  8/239 (3.35%)  11 6/242 (2.48%)  6
Rash acneiform  1  2/239 (0.84%)  2 1/242 (0.41%)  1
Rash desquamating  1  11/239 (4.60%)  15 5/242 (2.07%)  7
Skin disorder  1  12/239 (5.02%)  18 19/242 (7.85%)  29
Skin induration  1  1/239 (0.42%)  1 0/242 (0.00%)  0
Skin ulceration  1  0/239 (0.00%)  0 4/242 (1.65%)  4
Sweating  1  2/239 (0.84%)  3 4/242 (1.65%)  4
Vascular disorders     
Hematoma  1  6/239 (2.51%)  7 5/242 (2.07%)  5
Hemorrhage  1  0/239 (0.00%)  0 2/242 (0.83%)  2
Hot flashes  1  3/239 (1.26%)  3 2/242 (0.83%)  2
Hypertension  1  3/239 (1.26%)  3 7/242 (2.89%)  9
Hypotension  1  12/239 (5.02%)  13 8/242 (3.31%)  9
Lymph leakage  1  0/239 (0.00%)  0 1/242 (0.41%)  1
Thrombosis  1  10/239 (4.18%)  14 9/242 (3.72%)  10
Vascular disorder  1  1/239 (0.42%)  1 1/242 (0.41%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tonia M. Young-Fadok, M.D.
Organization: Mayo Clinic
EMail: youngfadok.tonia@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00726622     History of Changes
Other Study ID Numbers: ACOSOG-Z6051
ACOSOG-Z6051
U10CA076001 ( U.S. NIH Grant/Contract )
NCI-2009-00350 ( Other Identifier: NCI Clinical Trial Reporting Office )
CDR0000601816 ( Registry Identifier: NCI Physician Data Query )
First Submitted: July 31, 2008
First Posted: August 1, 2008
Results First Submitted: August 11, 2016
Results First Posted: November 11, 2016
Last Update Posted: July 9, 2019