Trial Outcomes & Findings for S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer (NCT NCT01224665)

Last Updated: 2024-11-29

Results Overview

Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence.

Recruitment status

COMPLETED

Study phase

Target enrollment

658 participants

Primary outcome timeframe

Duration of treatment and follow-up until death or 6 years after randomization

Results posted on

2024-11-29

Participant Flow

658 participants were enrolled to Step 1 before surgery. 40 of participants did not undergo randomization primarily due to results of their intraoperative assessment. Thus, 618 participants were randomized to Step 2; 315 on the standard LND arm and 303 on the extended LND arm. 26 randomized participants were deemed ineligible. Which leaves a total of 592 randomized and eligible participants, 300 and 292 on the standard and extended LND, respectively.

Participant milestones

Participant milestones
Measure	Standard LND Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Overall Study STARTED	300	292
Overall Study COMPLETED	300	292
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy	Total n=592 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	69 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	56 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	234 Participants n=5 Participants	236 Participants n=7 Participants	470 Participants n=5 Participants
Race/Ethnicity, Customized White	271 Participants n=5 Participants	265 Participants n=7 Participants	536 Participants n=5 Participants
Race/Ethnicity, Customized Black	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Other, Multiracial, Unknown	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	21 Participants n=7 Participants	27 Participants n=5 Participants
Body Mass Index (BMI)	27.3 kg/m^2 n=5 Participants	27.3 kg/m^2 n=7 Participants	27.3 kg/m^2 n=5 Participants
Zubrod Performance Status of 0 or 1 0-1	295 Participants n=5 Participants	288 Participants n=7 Participants	583 Participants n=5 Participants
Zubrod Performance Status of 0 or 1 2	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Clinical T Stage T2	213 Participants n=5 Participants	208 Participants n=7 Participants	421 Participants n=5 Participants
Clinical T Stage T3 or T4a	87 Participants n=5 Participants	84 Participants n=7 Participants	171 Participants n=5 Participants
Hydronephrosis	74 Participants n=5 Participants	78 Participants n=7 Participants	152 Participants n=5 Participants
Mixed Histologic Subtypes	36 Participants n=5 Participants	12 Participants n=7 Participants	48 Participants n=5 Participants
Neoadjuvant Chemotherapy Any neoadjuvant chemotherapy	170 Participants n=5 Participants	166 Participants n=7 Participants	336 Participants n=5 Participants
Neoadjuvant Chemotherapy Cisplatin-based	146 Participants n=5 Participants	147 Participants n=7 Participants	293 Participants n=5 Participants
Neoadjuvant Chemotherapy Carboplatin-based	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Neoadjuvant Chemotherapy Other neoadjuvant chemotherapy	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Neoadjuvant Chemotherapy None	130 Participants n=5 Participants	126 Participants n=7 Participants	256 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of treatment and follow-up until death or 6 years after randomization

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
5-year Disease-free Survival (DFS)	60 percentage of participants	56 percentage of participants

SECONDARY outcome

Timeframe: Duration of treatment and follow-up until death or 6 years after randomization

Comparing 5-year overall survival (OS) in participants randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. Overall survival is defined as the time from date of randomization to date of death from any cause. Participants known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
5-year Overall Survival (OS)	63 percentage of participants	59 percentage of participants

SECONDARY outcome

Timeframe: Duration of surgery

Evaluating duration of surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Median Operative Time	5.3 hours Interval 4.5 to 6.6	5.9 hours Interval 5.1 to 7.0

SECONDARY outcome

Timeframe: From date of operation to 90 days post-operation

Evaluating duration of post-operative hospital stay in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Median Days in Hospital	6 days Interval 5.0 to 8.0	7 days Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Duration of surgery

Population: The overall number of nerve-sparing surgeries performed per arm is reported as well as the numbers for males and females on each arm. The standard LND arm has 234 male participants and 66 females, while the extended LND arm has 236 males and 56 females.

Evaluating the frequency of nerve sparing surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Use of Nerve Preservation Male · No	143 Participants	151 Participants
Use of Nerve Preservation Male · Unilateral	12 Participants	9 Participants
Use of Nerve Preservation Male · Bilateral	79 Participants	76 Participants
Use of Nerve Preservation Female · No	60 Participants	49 Participants
Use of Nerve Preservation Female · Unilateral	0 Participants	0 Participants
Use of Nerve Preservation Female · Bilateral	6 Participants	7 Participants
Use of Nerve Preservation Overall · No	203 Participants	200 Participants
Use of Nerve Preservation Overall · Unilateral	12 Participants	9 Participants
Use of Nerve Preservation Overall · Bilateral	85 Participants	83 Participants

SECONDARY outcome

Timeframe: Duration of surgery

Evaluating the number of positive lymph nodes removed during surgery as well as the total number of lymph nodes removed in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Lymph Node Counts Total lymph nodes removed	24 number of lymph nodes Interval 6.0 to 61.0	39 number of lymph nodes Interval 15.0 to 94.0
Lymph Node Counts Positive lymph nodes removed	1 number of lymph nodes Interval 1.0 to 16.0	2 number of lymph nodes Interval 1.0 to 35.0

SECONDARY outcome

Timeframe: From date of operation to 90 days post-operation

Evaluating the receipt of adjuvant chemotherapy in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. Participants that reported plans to start adjuvant chemotherapy are included in these counts.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Receipt of Adjuvant Chemotherapy	11 percentage of participants	11 percentage of participants

SECONDARY outcome

Timeframe: From date of operation to 90 days post-operation

Evaluating the frequency of post-operative local and retroperitoneal soft-tissue recurrence in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Frequency of Post-Operative Local Recurrence	9 percentage of participants	13 percentage of participants

SECONDARY outcome

Timeframe: From date of operation to 90 days post-operation

Evaluating perioperative morbidity (death within 30 days of surgery) and post-operative morbidity (death within 90 days of surgery) in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Outcome measures

Outcome measures
Measure	Standard LND n=300 Participants Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 Participants Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Post-Operative Morbidity Death within 30 days	1 Participants	8 Participants
Post-Operative Morbidity Death within 90 days	7 Participants	19 Participants

Adverse Events

Standard LND

Serious events: 3 serious events

Other events: 226 other events

Deaths: 117 deaths

Extended LND

Serious events: 12 serious events

Other events: 219 other events

Deaths: 124 deaths

Serious adverse events

Other adverse events

Additional Information

SWOG Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Standard LND n=300 participants at risk Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy	Extended LND n=292 participants at risk Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.33% 1/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Cardiac arrest	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Myocardial infarction	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Ventricular fibrillation	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Enterovesical fistula	0.33% 1/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Nausea	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Death NOS	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.0% 3/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Fatigue	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Pain	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Sudden death NOS	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Sepsis	0.67% 2/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.0% 3/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Fall	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Cardiac troponin I increased	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Creatinine increased	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Ejection fraction decreased	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Stroke	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.68% 2/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Hypotension	0.00% 0/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Thromboembolic event	0.33% 1/300 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.34% 1/292 • Duration of treatment and follow-up until death or 6 years after randomization 592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.