Trial Outcomes & Findings for Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer (NCT NCT00492778)

NCT ID: NCT00492778

Last Updated: 2023-03-29

Results Overview

The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm.

• Recruitment status: UNKNOWN
• Study phase: PHASE2
• Target enrollment: 165 participants
• Primary outcome timeframe: Median follow-up for progression-free survival was 62 months with a maximum of 128 months. Patients were followed from study entry until disease progression, death, or date of last contact
• Results posted on: 2023-03-29

Participant Flow

Enrollment onto this study began February 25, 2008. Enrollment of the study ended August 12, 2020 after 165 patients had been enrolled.

Participant milestones

Measure	Arm I (Brachytherapy, Radiation Therapy) Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost
Overall Study STARTED	82	83
Overall Study COMPLETED	74	82
Overall Study NOT COMPLETED	8	1

Reasons for withdrawal

Measure	Arm I (Brachytherapy, Radiation Therapy) Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost
Overall Study Ineligible by Pathology Review	8	1

Baseline Characteristics

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Baseline characteristics by cohort

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 Participants Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=82 Participants Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost	Total n=156 Participants Total of all reporting groups
Age, Customized < 60 years	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized 60-80 years	49 Participants n=5 Participants	59 Participants n=7 Participants	108 Participants n=5 Participants
Age, Customized > 80 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	82 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	74 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	74 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Tumor Location Both pelvis and vagina	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Tumor Location Pelvis only	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Tumor Location Vagina only	63 Participants n=5 Participants	71 Participants n=7 Participants	134 Participants n=5 Participants
Histology Endometrioid, grade 1 - usually considered non-aggressive and have the most favorable outcome.	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Histology Endometrioid, grade 2 - more likely to spread outside the uterus. Worse outcome than grade 1.	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Histology Endometrioid, grade 3 - usually more aggressive with a worse outcome than lower grade tumors.	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Histology Endometrioid, grade unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Histology Serous	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Histology Clear Cell	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Histology Mixed Epithelial	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Histology Adenocarcinoma, not specified	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Histology Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Median follow-up for progression-free survival was 62 months with a maximum of 128 months. Patients were followed from study entry until disease progression, death, or date of last contact

Population: Eligible and evaluable participants who experienced progression or died.

The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm.

Outcome measures

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 Participants Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=82 Participants Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost	Prognostic Group 3 Participants with other tumor location and serous or clear cell histology	Prognostic Group 4 Patients with other tumor location and other histology
Number of Participants With Disease Progression or Death.	27 Participants	35 Participants	—	—

SECONDARY outcome

Timeframe: Participants were followed from study entry until death or date of last contact. Median follow-up for overall survival was 62 months with a maximum of 128 months.

Population: Eligible and evaluable participants who died while being followed by study.

Overall survival is the period from study entry until death or date of last contact. The treatment regimens were compared with regard to overall survival.

Outcome measures

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 Participants Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=82 Participants Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost	Prognostic Group 3 Participants with other tumor location and serous or clear cell histology	Prognostic Group 4 Patients with other tumor location and other histology
Number of Participants That Experienced Death on Study	18 Participants	21 Participants	—	—

SECONDARY outcome

Timeframe: Median follow-up for progression-free survival was 62 months with a maximum of 128 months.

Population: Eligible and evaluable participants who experienced progression or died.

Participants were put in prognostic groups including baseline factors of tumor location (vagina only vs. all others) and histology (serious and clear cell vs. all others). They were assessed for prognostic associations with progression-free survival. Participant factors were collected at baseline. Participants were followed from study entry until disease progression, death, or date of last contact for progression-free survival.

Outcome measures

Measure	Arm I (Brachytherapy, Radiation Therapy) n=127 Participants Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=7 Participants Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost	Prognostic Group 3 Participants with other tumor location and serous or clear cell histology	Prognostic Group 4 n=22 Participants Patients with other tumor location and other histology
Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.	45 Participants	4 Participants	0 Participants	13 Participants

SECONDARY outcome

Timeframe: Maximum follow-up for adverse events was 61 months.

Population: Number of participants with reported adverse events of grade 3 or higher.

Number of treated participants with adverse events of grade 3 or higher. Graded by Common Terminology Criteria for Adverse Events version 3.0. Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years.

Outcome measures

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 Participants Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=76 Participants Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost	Prognostic Group 3 Participants with other tumor location and serous or clear cell histology	Prognostic Group 4 Patients with other tumor location and other histology
Number of Participants That Experienced Adverse Effects Grade 3 or Higher	37 Participants	49 Participants	—	—

Adverse Events

Arm I (Brachytherapy, Radiation Therapy)

Serious events: 3 serious events

Other events: 72 other events

Deaths: 18 deaths

Arm II (Brachytherapy, Radiation Therapy, Cisplatin)

Serious events: 12 serious events

Other events: 76 other events

Deaths: 21 deaths

Serious adverse events

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 participants at risk Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=82 participants at risk Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost
Immune system disorders Allergic Reaction/Hypersensitivity	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Conduction Abnml: Asystole	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Cardiac Ischemia/Infarction	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Hypotension	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Fistula, Gi - Small Bowel Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Colitis	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Vomiting	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Diarrhea	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Esophagus	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Thrombosis/Thrombus/Embolism	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Renal Failure	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.

Other adverse events

Measure	Arm I (Brachytherapy, Radiation Therapy) n=74 participants at risk Whole Pelvis Radiation 4500 cGy in 25 fractions to the whole pelvis (180 cGy/fraction) + Interstitial or Intracavitary Brachytherapy or external beam boost	Arm II (Brachytherapy, Radiation Therapy, Cisplatin) n=82 participants at risk Whole Pelvis Radiation 4500 cGy in 25 Fractions to the whole pelvis (180 cGy/fraction) + Weekly Cisplatin (40mg/m2/wk) + Interstitial or Intracavitary Brachytherapy or external beam boost
Immune system disorders Allergy/Immunology - Other	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Immune system disorders Allergic Reaction/Hypersensitivity	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Ear and labyrinth disorders Auditory/Ear - Other	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Ear and labyrinth disorders Hearing (Without Monitoring Program)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Ear and labyrinth disorders Tinnitus	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	13.4% 11/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Ear and labyrinth disorders Hearing (Monitoring Program)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Neutrophils	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	45.1% 37/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Platelets	29.7% 22/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	57.3% 47/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Blood/Bone Marrow - Other	9.5% 7/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Leukocytes	45.9% 34/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	74.4% 61/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Lymphopenia	14.9% 11/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	14.6% 12/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Hemoglobin	36.5% 27/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	61.0% 50/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Lymphedema-Related Fibrosis	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Lymphatics - Other	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Edema: Trunk/Genital	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Edema: Limb	20.3% 15/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	23.2% 19/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Blood and lymphatic system disorders Edema: Head And Neck	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Palpitations	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Cardiac Arrhythmia - Other	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders S/N Arrhythmia: Atrial Flutter	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders S/N Arrhythmia: Sinus Tachycardia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Vasovagal Episode	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders S/N Arrhythmia: Sinus Bradycardia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Cardiac Ischemia/Infarction	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Pulmonary Hypertension	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Hypertension	28.4% 21/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	20.7% 17/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Left Venticular Diastolic Dysfunction	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Lt Ventricular Systolic Dysfunction	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Cardiac General - Other	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Cardiac Troponin I (Ctni)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Cardiac disorders Hypotension	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Inr	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Coagulopathy - Other	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gu - Urinary Nos	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gu - Vagina	20.3% 15/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	14.6% 12/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Rectum	12.2% 9/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	11.0% 9/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Varices (Rectal)	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage/Pulmonary - Nose	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hematoma	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Anus	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Lower Gi Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage, Gi - Abdomen Nos	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Hemorrhage/Bleeding - Other	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Thrombosis/Embolism (Vascular Access-Related)	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Thrombosis/Thrombus/Embolism	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Vascular disorders Phlebitis	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Constitutional Symptoms - Other	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Sweating	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Weight Gain	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Patient Odor	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Fever	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Weight Loss	14.9% 11/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Obesity	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Rigors/Chills	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Fatigue	70.3% 52/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	78.0% 64/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Insomnia	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	22.0% 18/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain - Other	9.5% 7/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	13.4% 11/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Urethra	12.2% 9/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	9.8% 8/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Perineum	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Pelvis	16.2% 12/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Breast	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Vagina	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Chest /Thorax Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Chest Wall	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Head/Headache	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	22.0% 18/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Neck	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Intestine	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Extremity-Limb	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	8.5% 7/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Buttock	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Back	16.2% 12/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	19.5% 16/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Joint	14.9% 11/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	14.6% 12/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Bone	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Lymph Node	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Bladder	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Pain Nos	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Stomach	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Rectum	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Abdominal Pain Nos	35.1% 26/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	17.1% 14/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Skin	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Lip	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Middle Ear	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: External Ear	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Cardiac/ Heart	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Muscle	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Anus	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Pain: Neuralgia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
General disorders Flu-Like Syndrome	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Nail Changes	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Injection Site Reaction	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Dermatitis - Chemoradiation	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Hypopigmentation	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Bruising	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Rash	10.8% 8/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	23.2% 19/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Dry Skin	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Atrophy, Skin	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Dermatitis - Radiation	14.9% 11/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	8.5% 7/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Telangiectasia	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Burn	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Flushing	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Hyperpigmentation	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Skin and subcutaneous tissue disorders Ulceration	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Endocrine disorders Hot Flashes	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Endocrine disorders Diabetes	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Endocrine disorders Hypothyroidism	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Enteritis	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Proctitis	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Flatulence	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Fistula, Gi - Rectum	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Hemorrhoids	12.2% 9/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	8.5% 7/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Ulcer,gi - Rectum	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Heartburn	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Ileus	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Dysphagia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Distention	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Taste Alteration	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	18.3% 15/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Incontinence, Anal	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Dry Mouth	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Rectum	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Colitis	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Vomiting	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	22.0% 18/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Anorexia	25.7% 19/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	29.3% 24/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Dehydration	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	12.2% 10/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Constipation	28.4% 21/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	35.4% 29/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Nausea	37.8% 28/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	64.6% 53/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Gastrointestinal - Other	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Gastrointestinal disorders Diarrhea	83.8% 62/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	79.3% 65/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vulva	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Blood	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Wound	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Lung (Pneumonia)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Blood	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Infection - Other	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Vagina	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Eye Nos	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Urinary Tract Nos	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Bladder (Urinary)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Dental-Tooth	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf Unknown Anc: Skin (Cellulitis)	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Infections and infestations Inf W/Gr 3 Or 4 Anc: Catheter-Related	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Ast	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	9.8% 8/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Gfr	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Cholesterol,serum High	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Proteinuria	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Creatinine	12.2% 9/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	19.5% 16/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypoalbuminemia	10.8% 8/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	17.1% 14/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Ggt	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Alt	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	13.4% 11/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Alkaline Phosphatase	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Bilirubin	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypophosphatemia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	9.8% 8/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hyponatremia	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	25.6% 21/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypertriglyceridemia	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Acidosis	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypernatremia	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypocalcemia	14.9% 11/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	28.0% 23/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hyperkalemia	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hyperglycemia	16.2% 12/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	31.7% 26/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypokalemia	18.9% 14/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	23.2% 19/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypoglycemia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypercalcemia	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Metabolism and nutrition disorders Hypomagnesemia	12.2% 9/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	35.4% 29/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Musculoskeletal/St: Other	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Osteoporosis	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Fracture	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Gait/Walking	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Arthritis	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	6.1% 5/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	11.0% 9/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Upper	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Syncope	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Psychosis	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Neurology - Other	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Apnea	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Encephalopathy	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Mood Alteration - Euphoria	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Mood Alteration - Depression	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	8.5% 7/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Mood Alteration - Anxiety	10.8% 8/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	13.4% 11/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Mood Alteration - Agitation	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Tremor	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Speech Impairment	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Seizure	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Confusion	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Memory Impairment	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Dizziness	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	12.2% 10/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Neuropathy-Sensory	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	22.0% 18/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Nervous system disorders Neuropathy-Motor	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Eye disorders Ocular/Visual - Other	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Eye disorders Cataract	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Eye disorders Blurred Vision	4.1% 3/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	3.7% 3/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Nasal/Paranasal Reactions	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Edema, Larynx	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Cough	10.8% 8/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	12.2% 10/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 13/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	24.4% 20/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Renal/Genitourinary - Other	13.5% 10/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	9.8% 8/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Stricture, Anastomotic, Gu - Vagina	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Stricture, Anastomotic, Gu - Ureter	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Leak, Gu - Urethra	2.7% 2/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Cystitis	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	11.0% 9/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Urinary Color Change	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Urinary Retention	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	7.3% 6/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Obstruction, Gu - Urethra	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Incontinence, Urinary	10.8% 8/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	18.3% 15/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Fistula, Gu - Vagina	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Bladder Spasm	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Renal Failure	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Renal and urinary disorders Urinary Frequency	29.7% 22/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	25.6% 21/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Libido	0.00% 0/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Irregular Menses	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Vaginal Dryness	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Sexual/Reproductive Function: Other	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	9.8% 8/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Vaginitis	6.8% 5/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	2.4% 2/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Vaginal Stenosis	8.1% 6/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	4.9% 4/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Vaginal Mucositis	5.4% 4/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	1.2% 1/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Reproductive system and breast disorders Vaginal Discharge	23.0% 17/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	17.1% 14/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.
Surgical and medical procedures Intra-Op Injury: Bone	1.4% 1/74 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.	0.00% 0/82 • Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.

Additional Information

Linda Gedeon for Danielle Enserro, PhD.

NRG Oncology

Phone: 7168451169

Email: gedeonl@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60